Evaluation of the best approach to retreating recurrent malaria in Ugandan children
ISRCTN | ISRCTN99046537 |
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DOI | https://doi.org/10.1186/ISRCTN99046537 |
Secondary identifying numbers | 1.2 |
- Submission date
- 30/11/2007
- Registration date
- 21/02/2008
- Last edited
- 10/07/2013
- 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 Ambrose Talisuna
Scientific
Scientific
Epidemiology and Surveillance Division
Uganda Ministry of Health Headquarters
P.O. Box 7272
Kampala
-
Uganda
Phone | +256 (0)414 345 887 |
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atalisuna@yahoo.com |
Study information
Study design | Nested phase IV, randomised, single blinded, multi-arm clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Comparison of quinine, artemether lumefantrine and dihydroartemisinin piperaquine for retreatment of recurrent malaria in Ugandan children |
Study objectives | There is no difference in the efficacy and safety of quinine and two artemisinin-based combination therapies (ACTs) (artemether lumefantrine [AL] and dihydroartemisinin piperaquine [DP]) for treatment of recurrent uncomplicated malaria. |
Ethics approval(s) | Ethics approval received from: 1. Makerere University Faculty of Medicine Research and Ethics Committee on 5th October 2007 2. The Uganda National Council of Science and Technology on 9th November 2007 (ref: HS 362) |
Health condition(s) or problem(s) studied | Malaria |
Intervention | The patients will be randomised to either quinine or another ACT regimen: 1. AL to quinine or DP 2. Chlorproguanil hydrochloride-dapsone-artesunate [CDA] to quinine 3. AL or DP 4. DP to quinine or AL Patients are then followed for 28 days to assess their response to therapy. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase IV |
Drug / device / biological / vaccine name(s) | Artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DP), quinine, chlorproguanil hydrochloride-dapsone-artesunate (CDA) |
Primary outcome measure | 1. Polymerase chain reaction (PCR) unadjusted treatment failure up to day 28 2. PCR adjusted treatment failure up to day 28 |
Secondary outcome measures | 1. Fever clearance time 2. Asexual parasite clearance time 3. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment 4. Haemoglobin (Hb) changes day 28 or day of treatment failure 5. Change in the frequency of plasmodial genetic polymorphisms (pfmdr1) as longitudinal markers of antimalarial drug resistance 6. Safety profiles including significant changes in relevant laboratory values |
Overall study start date | 01/12/2007 |
Completion date | 01/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 5 Years |
Sex | Both |
Target number of participants | 260 |
Key inclusion criteria | 1. Males and females aged between 1 and 5 years inclusive 2. Recurrent Plasmodium falciparum infection after treatment with ACTs in a related main study 3. Parents' or guardiansÂ’ willingness and ability to comply with the study protocol for the duration of the trial |
Key exclusion criteria | 1. Known hypersensitivity to the study drugs 2. Severe malaria 3. Danger signs: 3.1. Not able to drink or breast-feed 3.2. Vomiting (greater than twice in 24 hours) 3.3. Recent history of convulsions (greater than 1 in 24 hours) 3.4. Unconscious state 3.5. Unable to sit or stand 4. Early treatment failure in the main study |
Date of first enrolment | 01/12/2007 |
Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Epidemiology and Surveillance Division
Kampala
-
Uganda
-
Uganda
Sponsor information
Uganda Malaria Surveillance Project (Uganda)
Research organisation
Research organisation
P.O. Box 7475
Kampala
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Uganda
Phone | +256 (0)414 530 692 |
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ctugaineyo@muucsf.org | |
Website | http://www.muucsf.org |
Funders
Funder type
Research organisation
Department for International Development (DFID) (UK) - through Malaria Consortium (ref: SUBK026(2))
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/11/2013 | Yes | No |