Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability
| ISRCTN | ISRCTN75606663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75606663 |
| Secondary identifying numbers | Version 1.1 |
- Submission date
- 06/07/2006
- Registration date
- 17/08/2006
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Grant Dorsey
Scientific
Scientific
University of California, San Francisco (UCSF)
Box 0811
San Francisco
CA 94143
United States of America
| Phone | +1 415 206 8687 |
|---|---|
| gdorsey@medsfgh.ucsf.edu |
Study information
| Study design | Randomised, single-blinded trial of two leading new antimalarial regimens at three sites with varying transmission intensity. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability |
| Study acronym | AL vs DP efficacy and safety trial |
| Study hypothesis | To compare the efficacy, safety, and tolerability of Artemether-Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DP) for the treatment of uncomplicated falciparum malaria in Uganda. |
| Ethics approval(s) | 1. Ugandan National Council of Science and Technology (HS 112; February 14 2006) 2. University of California San Francisco Committee for Human Research (H9926-28076-01; January 11 2006) 3. Makerere University Faculty of Medicine Research and Ethics Committee (January 31 2006). |
| Condition | Malaria (P.falciparum) |
| Intervention | Subjects will be randomised to treatment with AL or DP. Subjects in the DP arm will also receive placebo tablets to ensure that the number of doses received is identical in the two treatment groups. Subjects who fail initial therapy will receive quinine, the standard treatment for recurrent malaria in Uganda. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artemether-lumefantrine and dihydroartemisinin-piperaquine |
| Primary outcome measure | Risk of treatment failure unadjusted and adjusted by genotyping at day 42 |
| Secondary outcome measures | 1. Prevalence of fever on days one to three 2. Prevalence of parasitemia on days two and three 3. Change in mean hemoglobin level between days zero and 42 (or day of treatment failure) 4. Prevalence of gametocytes during follow-up 5. Risk of serious adverse events during follow-up 6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy 7. Selection of molecular markers associated with drug resistance |
| Overall study start date | 20/03/2006 |
| Overall study end date | 20/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 1. Aged six months to ten years 2. Weight more than 5 kg 3. Fever (more than 37.5°C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 42 days 5. Plasmodium falciparum mono-infection 6. Parasite density more than 2000/µl and less than 200,000/µl |
| Participant 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 zero |
| Recruitment start date | 20/03/2006 |
| Recruitment end date | 20/07/2006 |
Locations
Countries of recruitment
- Uganda
- United States of America
Study participating centre
University of California, San Francisco (UCSF)
San Francisco
CA 94143
United States of America
CA 94143
United States of America
Sponsor information
Uganda Malaria Surveillance Project (Uganda)
Government
Government
Mulago Hospital Complex
P.O.Box 7475
Kampala
-
Uganda
| Phone | +256 41 530 692 |
|---|---|
| info@muucsf.org | |
| Website | http://www.muucsf.org |
Funders
Funder type
Government
Centers for Disease Control and Prevention/Global Malaria Prevention and Control Cooperative agreement number U50/CCU925112-01
No information available
Department for International Development (DFID) through Malaria Consortium (SUBK0001)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 18/05/2007 | Yes | No | ||
| Results article | 11/06/2008 | Yes | No |
Editorial Notes
25/10/2022: Internal review.
