MalariaPhase 4NCT00294580
Early Childhood Malaria Prevention With Maloprim in The Gambia
A Phase 4 study testing Maloprim in people with Malaria, run by Imperial College London at 1 site in The Gambia.
Trial summary
A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Maloprim
- How many people
- 2,253 participants
- Where
- 1 siteThe Gambia
- Study dates
- Apr 1982to Sep 2001
- Phase
- Phase 4
- 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 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For original trial: Children aged 3-59 months present in participating villages
- For follow-up: Children who were in original trial for at least 1 year.
Who cannot join
- For original trial: None
- For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests
Trial locations and contacts
1 site in 1 country.
The Gambia1 site
Medical Research Council Field Station
Farafenni, Central River Division
About this study
Official title: Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia
A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term
Read the detailed description
Two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of The Gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. Treatment alone did not have any significant effect on mortality or morbidity from malaria. In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children at the end of the trial.
14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. Associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). There was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis
- Conditions
- Malaria
- Being tested
- Maloprim
- Keywords
- Malaria, Cognition, Prevention & control, Anemia, Chemoprophylaxis, Mortality, Children, Randomized controlled trial, Education, Long-term effects, The Gambia, Africa, West
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaloprimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Episodes of Fever Associated with Malaria Parasitaemia
Cognitive Abilities in late adolescence
Educational Attainment (Years spent at school)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startApr 1982
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 2,253 participants
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Government of the Gambia, London School of Hygiene and Tropical Medicine, Partnership for Child Development, Wellcome Trust
- Investigators
- Brian M Greenwood, MD, Principal investigator, London School of Hygiene and Tropical MedicineMatthew CH Jukes, DPhil, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294580
- Sponsor's protocol ID
- SCC-795-835
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2006
- Last updated
- 3 Oct 2023
- Results posted
- No
Publications
Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, N'Jie AB. Comparison of two strategies for control of malaria within a primary health care programme in the Gambia. Lancet. 1988 May 21;1(8595):1121-7. doi: 10.1016/s0140-6736(88)91949-6.
PubMed 2896957Menon A, Snow RW, Byass P, Greenwood BM, Hayes RJ, N'Jie AB. Sustained protection against mortality and morbidity from malaria in rural Gambian children by chemoprophylaxis given by village health workers. Trans R Soc Trop Med Hyg. 1990 Nov-Dec;84(6):768-72. doi: 10.1016/0035-9203(90)90071-l.
PubMed 2096501Greenwood BM, David PH, Otoo-Forbes LN, Allen SJ, Alonso PL, Armstrong Schellenberg JR, Byass P, Hurwitz M, Menon A, Snow RW. Mortality and morbidity from malaria after stopping malaria chemoprophylaxis. Trans R Soc Trop Med Hyg. 1995 Nov-Dec;89(6):629-33. doi: 10.1016/0035-9203(95)90419-0.
PubMed 8594677
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia
- ClinicalTrials.gov ID
- NCT00294580
- Acronym / sponsor ID
- SCC-795-835
- Conditions
- Malaria
- Keywords
- Malaria, Cognition, Prevention & control, Anemia, Chemoprophylaxis, Mortality, Children, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,253 participants
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Government of the Gambia, London School of Hygiene and Tropical Medicine, Partnership for Child Development, Wellcome Trust
- Study start
- Apr 1982
- Study completion
- Sep 2001
- First posted
- 22 Feb 2006 (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.
A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term
Detailed description
Two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of The Gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. Treatment alone did not have any significant effect on mortality or morbidity from malaria. In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children at the end of the trial.
14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. Associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). There was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- For original trial: Children aged 3-59 months present in participating villages
- For follow-up: Children who were in original trial for at least 1 year.
Key exclusion criteria (2 listed)
- For original trial: None
- For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests
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 |
|---|---|---|
| Maloprim | Drug | – |
Primary outcome
Mortality
Episodes of Fever Associated with Malaria Parasitaemia
Cognitive Abilities in late adolescence
Educational Attainment (Years spent at school)
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 3 Oct 2023.
- Results publication: PubMed 2896957Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, N'Jie AB. Comparison of two strategies for control of malaria within a primary health care programme in the Gambia. Lancet. 1988 May 21;1(8595):1121-7. doi: 10.1016/s0140-6736(88)91949-6.
- Results publication: PubMed 2096501Menon A, Snow RW, Byass P, Greenwood BM, Hayes RJ, N'Jie AB. Sustained protection against mortality and morbidity from malaria in rural Gambian children by chemoprophylaxis given by village health workers. Trans R Soc Trop Med Hyg. 1990 Nov-Dec;84(6):768-72. doi: 10.1016/0035-9203(90)90071-l.
- Results publication: PubMed 8594677Greenwood BM, David PH, Otoo-Forbes LN, Allen SJ, Alonso PL, Armstrong Schellenberg JR, Byass P, Hurwitz M, Menon A, Snow RW. Mortality and morbidity from malaria after stopping malaria chemoprophylaxis. Trans R Soc Trop Med Hyg. 1995 Nov-Dec;89(6):629-33. doi: 10.1016/0035-9203(95)90419-0.
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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.
Brian M Greenwood, MD principal investigator
London School of Hygiene and Tropical Medicine
Matthew CH Jukes, DPhil principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maloprim in people with Malaria, run by Imperial College London at 1 site in The Gambia.
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 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 3 Oct 2023. 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 The Gambia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mortality. The study lists 4 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 NCT00294580, which also lists 3 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 3 Oct 2023.