Evaluation of the best approach to retreating recurrent malaria in Ugandan children

ISRCTN ISRCTN99046537
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

Epidemiology and Surveillance Division
Uganda Ministry of Health Headquarters
P.O. Box 7272
Kampala
-
Uganda

Phone +256 (0)414 345 887
Email atalisuna@yahoo.com

Study information

Study designNested phase IV, randomised, single blinded, multi-arm clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComparison of quinine, artemether lumefantrine and dihydroartemisinin piperaquine for retreatment of recurrent malaria in Ugandan children
Study objectivesThere 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) studiedMalaria
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DP), quinine, chlorproguanil hydrochloride-dapsone-artesunate (CDA)
Primary outcome measure1. Polymerase chain reaction (PCR) unadjusted treatment failure up to day 28
2. PCR adjusted treatment failure up to day 28
Secondary outcome measures1. 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 date01/12/2007
Completion date01/12/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit5 Years
SexBoth
Target number of participants260
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2007
Date of final enrolment01/12/2008

Locations

Countries of recruitment

  • Uganda

Study participating centre

Epidemiology and Surveillance Division
Kampala
-
Uganda

Sponsor information

Uganda Malaria Surveillance Project (Uganda)
Research organisation

P.O. Box 7475
Kampala
-
Uganda

Phone +256 (0)414 530 692
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2013 Yes No