MalariaNCT01954264

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

A study testing Capillary blood sample and Data collection in people with Malaria, run by GlaxoSmithKline at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western… Read more about this study

Who is it for?: Ages 6 months to 9 yearsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: Capillary blood sample and Data collection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,421 participants
Where: 3 sitesin 2 countries
Study dates: 19 Oct 2013to 25 Nov 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Who cannot join

Child in care.
Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Burkina Faso2 sites

GSK Investigational Site
Nouna
GSK Investigational Site
Ouagadougou

Other trials in Burkina Faso

Senegal1 site

GSK Investigational Site
Dakar

Other trials in Senegal

About this study

Official title: Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa

Read the detailed description

Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - <10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (<5 years).

Conditions: Malaria
Being tested: Capillary blood sample, Data collection
Keywords: Saharan Western Africa, Epidemiology, Post-Approval Programme study, Malaria, Burden of Disease Study
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capillary blood sampleProcedure or surgery
Capillary blood sample (up to 200µL) for determination of PP (blood slides).
Data collectionOther
Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)

Study groups in NCT01954264
Study group	Role	What they receive
Overall Study Group	Other	Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. Receives: Procedure: Capillary blood sample; Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Malaria Control Interventions (MCIs), Overall
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)

Secondary outcomes (18)

Number of Subjects With Other Medical History Characteristics, Overall
The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS).
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by Age, According to P. Falciparum Infection Status
The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status
The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by Gender, According to P. Falciparum Infection Status
The gender characteristics were summarized by P. falciparum infection status.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers
Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Anti-malarial Therapy, Overall
Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Days With Therapy, Overall
The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Days of Malaria Treatment, Overall
This endpoint presents results per total centers and across all age categories.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Fever, Overall
Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Days With Fever, Overall
This endpoint presents results per total centers and across all age categories.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With P. Falciparum by Situation Area, Overall
The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 \& < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Densities by Situation Area and Center
The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 \& < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).
Measured: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Measured: At Epoch 1 (Survey visit) (approximately 35 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 201325 Nov 2013

First posted1 Oct 2013 (estimated)
Study start19 Oct 2013
Primary completion22 Nov 2013
Study completion25 Nov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,421 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01954264
Sponsor's protocol ID: 200187
Status last verified: Jan 2020
First submitted: 19 Sep 2013
Last updated: 21 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below).

Publications

Diallo A, Sie A, Sirima S, Sylla K, Ndiaye M, Bountogo M, Ouedraogo E, Tine R, Ndiaye A, Coulibaly B, Ouedraogo A, Faye B, Ba EH, Compaore G, Tiono A, Sokhna C, Ye M, Diarra A, Bahmanyar ER, De Boer M, Pircon JY, Usuf EA. An epidemiological study to assess Plasmodium falciparum parasite prevalence and malaria control measures in Burkina Faso and Senegal. Malar J. 2017 Feb 6;16(1):63. doi: 10.1186/s12936-017-1715-1.
PubMed 28166794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

All Malaria trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa
ClinicalTrials.gov ID: NCT01954264
Acronym / sponsor ID: 200187
Conditions: Malaria
Keywords: Saharan Western Africa, Epidemiology, Post-Approval Programme study, Malaria, Burden of Disease Study
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,421 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Oct 2013 (actual)
Primary completion: 22 Nov 2013 (actual)
Study completion: 25 Nov 2013 (actual)
First posted: 1 Oct 2013 (estimated)
Results: Posted 5 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Overall Study Group	Other	Procedure: Capillary blood sample, Other: Data collectionSubjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.

Who may qualify

Ages: 6 months to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Key exclusion criteria (2 listed)

Child in care.
Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capillary blood sampleCapillary blood sample (up to 200µL) for determination of PP (blood slides).	Procedure or surgery	Overall Study Group
Data collectionProspective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)	Other	Overall Study Group

Primary outcome

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.
Number of Subjects With Malaria Control Interventions (MCIs), Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.

18 secondary outcomes

Number of Subjects With Other Medical History Characteristics, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by Age, According to P. Falciparum Infection Status
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects by Gender, According to P. Falciparum Infection Status
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Anti-malarial Therapy, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Days With Therapy, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Days of Malaria Treatment, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Fever, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Days With Fever, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With P. Falciparum by Situation Area, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Densities by Situation Area and Center
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)
Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center
Time frame: At Epoch 1 (Survey visit) (approximately 35 days)

Results and safety

Results posted to the registry on 5 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study Group	2,421	2,421

Primary outcome: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center

Time frame: At Epoch 1 (Survey visit) (approximately 35 days). Count of participants. Unit: Participants

Measure	0.5-4Y Group n = 1614	5-9Y Group n = 807
NOU-BF	235	153
OUA-BF	167	141
DA-1-SE	2	1
DA-2-SE	5	3
Total	409	298

Population analysed: The According to Protocol (ATP) cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.

Primary outcome: Number of Subjects With Malaria Control Interventions (MCIs), Overall

Time frame: At Epoch 1 (Survey visit) (approximately 35 days). Count of participants. Unit: Participants

Measure	Overall Study Group n = 2421
UMc > 7D, Yes	122
UMc > 7D, Missing/No	2299
UIs > 7D, Yes	65
UIs > 7D, Missing/No	2356
UCR > 7D, Yes	12
UCR > 7D, Missing/No	2409
UTR > 7D, Yes	278
UTR > 7D, Missing/No	2143

Population analysed: The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.

Primary outcome: Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status

Time frame: At Epoch 1 (Survey visit) (approximately 35 days). Count of participants. Unit: Participants

Measure	PF-INF Group n = 707	NOT-INF Group n = 1714
Use of Mosquito coils over 7 days	39	83
Use of insecticide sprays over 7 days	15	50
Use of commercial repellents over 7 days	4	8
Use of traditional repellents over 7 days	3	275
Use of none of the above over 7 days	649	1330
Use of indoor residual spray in past 12 months	3	86
Use of indoor residual spray in past 1 month	0	0
Use of indoor residual spray in past 2 months	1	59

Population analysed: The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.

Primary outcome: Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso

Time frame: At Epoch 1 (Survey visit) (approximately 35 days). Number (95% Confidence Interval). Unit: Unadjusted Odds Ratio

Measure	PF-INF Group n = 388
MT PAST 14D, YES VS. NO	0.323 (0.215 to 0.484)
NDMT, ≥4 DAYS VS. ONGOING	0.917 (0.051 to 16.494)
NDMT, 1-3 DAYS VS. ONGOING	0.596 (0.239 to 1.483)
OM PAST 14D, YES VS. NO	0.563 (0.403 to 0.788)
NDOM, 1-7 DAYS VS. ONGOING	1.155 (0.643 to 2.077)
NDOM, ≥8 DAYS VS. ONGOING	NA (NA to NA)
WSH3MM, YES VS. NO	0.612 (0.266 to 1.411)
SSUMNNBV, YES VS. NO	0.447 (0.165 to 1.216)

Population analysed: The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study Group	0 of 2,421 (0%)	0 of 0	0 of 2,421

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28166794Diallo A, Sie A, Sirima S, Sylla K, Ndiaye M, Bountogo M, Ouedraogo E, Tine R, Ndiaye A, Coulibaly B, Ouedraogo A, Faye B, Ba EH, Compaore G, Tiono A, Sokhna C, Ye M, Diarra A, Bahmanyar ER, De Boer M, Pircon JY, Usuf EA. An epidemiological study to assess Plasmodium falciparum parasite prevalence and malaria control measures in Burkina Faso and Senegal. Malar J. 2017 Feb 6;16(1):63. doi: 10.1186/s12936-017-1715-1.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below).

Related trials for Malaria

Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Capillary blood sample and Data collection in people with Malaria, run by GlaxoSmithKline at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Burkina Faso, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center (time frame: At Epoch 1 (Survey visit) (approximately 35 days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.