MalariaNCT00720811
Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
A study testing Artemether-lumefantrine combination, amoxycillin and paracetamol in people with Malaria and Pneumonia, run by Mbarara University of Science and Technology at 4 sites in 3 countries.
Trial summary
This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. Read more about this study
- Who is it for?
- Ages 4 to 59 months
- What is being tested?
- Artemether-lumefantrine combination, amoxycillin and paracetamol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,456 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2009to Jan 2012
- 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 4 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor
Who cannot join
- Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.
Read the detailed description
This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.
- Being tested
- Artemether-lumefantrine combination, amoxycillin, paracetamol, malaria rapid diagnostic test, respiratory rate timer
- Keywords
- Malaria ACT, Rapid, Diagnosis, Community, health, worker, Artemesinin, based, Combination, Therapy, Anti Malarial, Treatment, antibiotics
- Medical subject headings
- Malaria, Pneumonia, Fasting, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combinationDrug
Also called Coartem
20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days
amoxycillinDrug
amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
paracetamolDrug
paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
malaria rapid diagnostic test, respiratory rate timerDevice
malaria dipstick, and breath timer
Artemether-lumefantrine combinationDrug
20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2
| Study group | Role | What they receive |
|---|---|---|
| ACT, antibiotic, paracetamol | Experimental | CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C. Receives: Drug: Artemether-lumefantrine combination; Drug: amoxycillin; Drug: paracetamol; Device: malaria rapid diagnostic test, respiratory rate timer |
| Presumptive fever management | No intervention | Presumptive treatment of malaria with ACTs. No antibiotic treatment available Receives: Drug: Artemether-lumefantrine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate from fever at Day 3
Measured: Day 3
Secondary outcomes (2)
use of antimalarial and antibiotic drugs by community health workers
Measured: After patient enrollment
Recovery rate from fever at Day 7
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Ministry of Health, Uganda, Navrongo Health Research Centre, Ghana, National Malaria Research and Training Centre, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Francis Bajunirwe, MBChB PhD, Study director, Mbarara University of Science and TechnologyGeorge Pariyo, MB ChB, PhD, Study director, Makerere UniversityJames Tibenderana, MB ChB, PhD, Principal investigator, Malaria ConsortiumAlfred Tiono, PhD, Principal investigator, National Malaria Research and Training Center, Burkina FasoThomas Anyorigiya, MSc, Principal investigator, Navrongo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720811
- Sponsor's protocol ID
- A60487
- Status last verified
- Mar 2012
- First submitted
- 21 Jul 2008
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
- ClinicalTrials.gov ID
- NCT00720811
- Acronym / sponsor ID
- A60487
- Keywords
- Malaria ACT, Rapid, Diagnosis, Community, health, worker, Artemesinin, based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,456 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Makerere University, Ministry of Health, Uganda, Navrongo Health Research Centre, Ghana, National Malaria Research and Training Centre, Burkina Faso
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Jul 2008 (estimated)
- 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.
This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.
Detailed description
This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT, antibiotic, paracetamol | Experimental | Drug: Artemether-lumefantrine combination, Drug: amoxycillin, Drug: paracetamol, Device: malaria rapid diagnostic test, respiratory rate timerCHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C. |
| Presumptive fever management | No intervention | Drug: Artemether-lumefantrine combinationPresumptive treatment of malaria with ACTs. No antibiotic treatment available |
Who may qualify
- Ages
- 4 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor
Key exclusion criteria (1 listed)
- Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate
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 |
|---|---|---|
| Artemether-lumefantrine combinationAlso: Coartem20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days | Drug | ACT, antibiotic, paracetamol |
| amoxycillinamoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2 | Drug | ACT, antibiotic, paracetamol |
| paracetamolparacetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days | Drug | ACT, antibiotic, paracetamol |
| malaria rapid diagnostic test, respiratory rate timermalaria dipstick, and breath timer | Device | ACT, antibiotic, paracetamol |
| Artemether-lumefantrine combination20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2 | Drug | Presumptive fever management |
Primary outcome
Recovery rate from fever at Day 3
Time frame: Day 3
2 secondary outcomes
use of antimalarial and antibiotic drugs by community health workers
Time frame: After patient enrollment
Recovery rate from fever at Day 7
Time frame: Day 7
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 16 Mar 2012.
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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.
Francis Bajunirwe, MBChB PhD study director
Mbarara University of Science and Technology
George Pariyo, MB ChB, PhD study director
Makerere University
James Tibenderana, MB ChB, PhD principal investigator
Malaria Consortium
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemether-lumefantrine combination, amoxycillin and paracetamol in people with Malaria and Pneumonia, run by Mbarara University of Science and Technology at 4 sites in 3 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 1 inclusion and 1 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Uganda, Burkina Faso, Ghana. 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?
Recovery rate from fever at Day 3 (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2012.