Uganda Malaria Surveillance Project - Combination therapies for treatment of uncomplicated falciparum malaria in Uganda: evaluation of efficacy, safety, and tolerability
| ISRCTN | ISRCTN67520427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67520427 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/04/2005
- Registration date
- 10/05/2005
- Last edited
- 22/04/2008
- 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 of protocol
Not provided at time of registration
Contact information
Dr Arthur Reingold
Scientific
Scientific
University of California
104 Haviland Hall
Berkeley
94720-7360
United States of America
Study information
| Study design | Single-blind, randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | UMSP |
| Study objectives | To assess the efficacy, safety and tolerability of alternative antimalarial therapies for treatment of uncomplicated falciparum malaria as they compare to Chloroquine/Sulfadoxine-Pyrimethamine (CQ/SP) treatment. |
| Ethics approval(s) | No ethics information provided at time of registration. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Alternative therapies to chloroquine/sulfadoxine-pyrimethamine (CQ/SP) |
| Primary outcome measure | 1. 28-day risks for any recurrent infection 2. Recrudescence 3. New infections. |
| Secondary outcome measures | 1. Risk of recurrent infection unadjusted by genotyping at day 14 2. Presence of fever on days one to three 3. Parasitemia on days two and three 4. Change in haemoglobin level between the day of enrolment and the last day of follow-up 5. Presence of gametocytes during any follow-up day 6. Incidence of adverse events |
| Overall study start date | 01/11/2002 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Not Specified |
| Target number of participants | 2160 |
| Key inclusion criteria | 1. Aged over six months 2. Fever (more than 37.5 ºC axillary) or history of fever in the previous 24 hours 3. Absence of any history of serious side effects to study medications, including allergy to sulfa drugs 4. No evidence of severe malaria or danger signs 5. No evidence of a concomitant febrile illness 6. P. falciparum mono-infection 7. Parasite density more than 2000/ul and less than 200,000/ul 8. Agreement to return for all scheduled follow-up visits 9. Provision of informed consent 10. No history of anti-folate or amodiaquine use in past seven days 11. Absence of pregnancy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- Uganda
- United States of America
Study participating centre
University of California
Berkeley
94720-7360
United States of America
94720-7360
United States of America
Sponsor information
Uganda Malaria Surveillance Project (Uganda)
Government
Government
P.O. Box 7475
Kampala
7475
Uganda
| Phone | +256 41 530 692 |
|---|---|
| mkamya@infocom.co.ug |
Funders
Funder type
Government
Financial support was provided by the Centers for Disease Control/Association of Schools of Public Health cooperative agreement, Malaria Surveillance and Control in Uganda (SA3569 & S1932-21/21) and the Department for International Development (DFID)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2005 | Yes | No |
