MalariaNCT03705624

P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)

A study testing Enhanced Community Case Management (CCM) and Monthly Screening and Treatment (MSAT) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.

Completed

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

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: Enhanced Community Case Management (CCM) and Monthly Screening and Treatment (MSAT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 907 participants
Where: 1 siteBurkina Faso
Study dates: 6 Aug 2018to 14 Feb 2020
Phase: Interventional
Are there results?: None posted in the registry

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Participants should be permanent residents of the compound
Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children <10 years of age) or 52mL of blood (older individuals) during an 18-month period

Who cannot join

Any (chronic) illness that would affect with study participation
Pre-existing severe chronic health conditions
Current participation in malaria vaccine trials or participation in such trials in the last 2 years
History of intolerance to artemether-lumefantrine

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou

Other trials in Burkina Faso

About this study

In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season

Conditions: Malaria
Being tested: Enhanced Community Case Management (CCM), Monthly Screening and Treatment (MSAT)
Keywords: falciparum, gametocyte, elimination, anopheles, transmission, diagnostic
Medical subject headings: Malaria, Disease

What participants receive

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

Enhanced Community Case Management (CCM)Other
Enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with AL according to national guidelines
Monthly Screening and Treatment (MSAT)Other
Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.

Study groups in NCT03705624
Study group	Role	What they receive
Standard of Care	No intervention	Standard of care with passively monitored malaria incidence at health centers that receive appropriate diagnostic and clinical supplies and Seasonal Malaria Chemoprevention (SMC) for children less than 5 years of age
CCM	Experimental	Standard of care supplemented with enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with artemether-lumefantrine (AL) according to national guidelines Receives: Other: Enhanced Community Case Management (CCM)
CCM+MSAT	Experimental	Standard of Care supplemented with CCM and Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines. Receives: Other: Enhanced Community Case Management (CCM); Other: Monthly Screening and Treatment (MSAT)

What is being measured

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

Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2. If CCM and MSAT result in the early detection of infections, parasite prevalence at the end of the study will be lower in these arms compared to the control arm.
Measured: Month 18 (end of second transmission season; January-February 2020)

Secondary outcomes (8)

Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.
Parasite prevalence and density in the cross-sectional survey conducted at the end of the transmission season of year 1. If CCM and MSAT result in the early detection of infections, parasite prevalence will be lower in these arms compared to the control arm.
Measured: Month 6 (end of first transmission season; January-February 2019)
Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.
Parasite prevalence and density in the cross-sectional survey conducted at the end of the dry season. If CCM and MSAT result in the early detection of infections, parasite prevalence will be lower in these arms compared to the control arm.
Measured: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey
Gametocyte prevalence in qPCR detected infections is assessed by molecular methods and compared between study arms.
Measured: Month 18 (end of second transmission season; January-February 2020)
Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Measured: Month 6 (end of first transmission season; January-February 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Measured: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum during all study visits
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Measured: Throughout study, an average of 18 months
The number of incident infections.
Regular visits by CCM and MSAT will result in the identification of malaria infections that are not detected during passive case detection. The numbers of infections that are detected in each arm are quantified and compared between arms.
Measured: Throughout study, an average of 18 months
Infectivity to mosquitoes of P. falciparum infections
For a selection of infections, infectiousness to mosquitoes is assessed by membrane feeding assays.
Measured: Throughout study, an average of 18 months

Timeline

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

6 Aug 201814 Feb 2020

First posted15 Oct 2018
Study start6 Aug 2018
Primary completion14 Feb 2020
Study completion14 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: Cluster randomized trial
Masking: None (open label)
Enrolment: 907 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03705624
Sponsor's protocol ID: INDIE-1a
Status last verified: Aug 2018
First submitted: 19 Jul 2018
Last updated: 28 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Anonymised individual participant data may be shared on a digital repository or upon reasonable request.

Publications

Collins KA, Ouedraogo A, Guelbeogo WM, Soulama I, Ouattara MS, Sombie S, Ouedraogo N, Coulibaly AS, Nombre A, Lanke K, Ramjith J, Awandu SS, Serme SS, Henry N, Stone W, Ouedraogo IN, Diarra A, Holden TM, Sirima SB, Bradley J, Soremekun S, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono AB. Effect of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria parasites in Burkina Faso: a cluster-randomised trial. Lancet Microbe. 2024 Sep;5(9):100891. doi: 10.1016/S2666-5247(24)00114-9. Epub 2024 Jul 25.
PubMed 39068937
Collins KA, Ouedraogo A, Guelbeogo WM, Awandu SS, Stone W, Soulama I, Ouattara MS, Nombre A, Diarra A, Bradley J, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono A. Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial. BMJ Open. 2019 Sep 13;9(9):e030598. doi: 10.1136/bmjopen-2019-030598.
PubMed 31519680

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

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)
ClinicalTrials.gov ID: NCT03705624
Acronym / sponsor ID: INDIE-1a
Conditions: Malaria
Keywords: falciparum, gametocyte, elimination, anopheles, transmission, diagnostic
Study type: Interventional
Recruitment status: Completed
Enrolment: 907 participants (actual)
Lead sponsor: London School of Hygiene and Tropical MedicineUniversity, hospital or other
Collaborators: Centre national de recherche et de formation sur le paludisme, Radboud University Medical Center, Institute for Disease Modeling, Bellevue, US
Study start: 6 Aug 2018 (actual)
Primary completion: 14 Feb 2020 (actual)
Study completion: 14 Feb 2020 (actual)
First posted: 15 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Cluster randomized trial

Arm	Type	Receives
Standard of Care	No intervention	–Standard of care with passively monitored malaria incidence at health centers that receive appropriate diagnostic and clinical supplies and Seasonal Malaria Chemoprevention (SMC) for children less than 5 years of age
CCM	Experimental	Other: Enhanced Community Case Management (CCM)Standard of care supplemented with enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with artemether-lumefantrine (AL) according to national guidelines
CCM+MSAT	Experimental	Other: Enhanced Community Case Management (CCM), Other: Monthly Screening and Treatment (MSAT)Standard of Care supplemented with CCM and Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Participants should be permanent residents of the compound
Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children <10 years of age) or 52mL of blood (older individuals) during an 18-month period

Key exclusion criteria (4 listed)

Any (chronic) illness that would affect with study participation
Pre-existing severe chronic health conditions
Current participation in malaria vaccine trials or participation in such trials in the last 2 years
History of intolerance to artemether-lumefantrine

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
Enhanced Community Case Management (CCM)Enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with AL according to national guidelines	Other	CCM, CCM+MSAT
Monthly Screening and Treatment (MSAT)Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.	Other	CCM+MSAT

Primary outcome

Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
Time frame: Month 18 (end of second transmission season; January-February 2020)
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2. If CCM and MSAT result in the early detection of infections, parasite prevalence at the end of the study will be lower in these arms compared to the control arm.

8 secondary outcomes

Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.
Time frame: Month 6 (end of first transmission season; January-February 2019)
Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.
Time frame: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey
Time frame: Month 18 (end of second transmission season; January-February 2020)
Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey
Time frame: Month 6 (end of first transmission season; January-February 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey
Time frame: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum during all study visits
Time frame: Throughout study, an average of 18 months
The number of incident infections.
Time frame: Throughout study, an average of 18 months
Infectivity to mosquitoes of P. falciparum infections
Time frame: Throughout study, an average of 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Derived from this study: PubMed 39068937Collins KA, Ouedraogo A, Guelbeogo WM, Soulama I, Ouattara MS, Sombie S, Ouedraogo N, Coulibaly AS, Nombre A, Lanke K, Ramjith J, Awandu SS, Serme SS, Henry N, Stone W, Ouedraogo IN, Diarra A, Holden TM, Sirima SB, Bradley J, Soremekun S, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono AB. Effect of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria parasites in Burkina Faso: a cluster-randomised trial. Lancet Microbe. 2024 Sep;5(9):100891. doi: 10.1016/S2666-5247(24)00114-9. Epub 2024 Jul 25.
Derived from this study: PubMed 31519680Collins KA, Ouedraogo A, Guelbeogo WM, Awandu SS, Stone W, Soulama I, Ouattara MS, Nombre A, Diarra A, Bradley J, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono A. Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial. BMJ Open. 2019 Sep 13;9(9):e030598. doi: 10.1136/bmjopen-2019-030598.
Individual participant dataSharing planned: Undecided. Anonymised individual participant data may be shared on a digital repository or upon reasonable request.

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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.

Chris Drakeley, PhD principal investigator

London School of Hygiene and Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, United Kingdom

Alfred Tiono, PhD, MD principal investigator

Centre national de recherche et de formation sur le paludisme

Teun Bousema, PhD principal investigator

Radboud university medical centre, Nijmegen, The Netherlands

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Parasite prevalence and density by molecular detection at the end of study cross-sectional survey. (time frame: Month 18 (end of second transmission season; January-February 2020)). 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 NCT03705624, which also lists 2 linked publications.

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 28 Feb 2020.