Uganda Malaria Surveillance Project - Comparison of amodiaquine plus artesunate and artemether-lumefantrine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability
| ISRCTN | ISRCTN44534980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44534980 |
| Protocol serial number | N/A |
| Sponsor | Uganda Malaria Surveillance Project |
| Funder | Centers for Disease Control and Prevention/Association of Schools of Public Health cooperative agreement, 'Malaria Surveillance and Control in Uganda' (SA3569 and S1932-21/21), and the Department for International Development (DFID) |
- Submission date
- 04/11/2005
- Registration date
- 28/11/2005
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Fred Wabwire-Mangen
Scientific
Scientific
Institute Of Public Health
Makerere University
P.O. Box 7072
Kampala
-
Uganda
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | UMSP |
| Study objectives | To compare the efficacy, safety, and tolerability of amodiaquine + artesunate and artemether + lumefantrine for the treatment of uncomplicated falciparum malaria in Uganda. |
| Ethics approval(s) | Ugandan National Council of Science and Technology, University of California San Francisco Committee for Human Research, University of California Berkeley IRB |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Subjects will be randomized to treatment with amodiaquine + artesunate (AQ + AS) or artemether + lumefantrine (AL). Subjects in the AQ + AS arm will also receive placebo tablets to ensure that the number of doses received is identical in the two treatment groups. Subjects requiring repeat therapy (second-line therapy given for symptomatic malaria) will receive quinine. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amodiaquine + artesunate and artemether + lumefantrine |
| Primary outcome measure(s) | Primary outcome will be based on the risk of clinical rescue therapy. Pairwise comparisons between regimens will be made based on a per-protocol analysis. |
| Key secondary outcome measure(s) | 1. Risk of clinical treatment failure 2. Risk of parasitological rescue therapy 3. Risk of parasitological treatment failure 4. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 5. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on day 2 and day 3 6. Change in mean haemoglobin from day 0 to 28 or day of repeat therapy 7. Proportion of subjects lacking gametocytes on day 0 with gametocytaemia on any follow-up day 8. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 9. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures |
| Completion date | 14/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | 1. Age 1-10 years 2. Weight >10 kg 3. Fever (>37.5 °C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 28 days 5. P. falciparum mono-infection 6. Parasite density >2000/µl and <200,000/µl |
| Key exclusion criteria | 1. Previously enrolled in this study 2. History of serious side effects to study medications 3. Evidence of a concomitant febrile illness 4. Evidence of severe malaria or danger signs 5. Repeated vomiting of study medications on day 0 |
| Date of first enrolment | 14/12/2004 |
| Date of final enrolment | 14/07/2005 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Institute Of Public Health
Kampala
-
Uganda
-
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
