Contact information
Type
Scientific
Primary contact
Dr Ambrose Talisuna
ORCID ID
Contact details
Epidemiology and Surveillance Division
Uganda Ministry of Health Headquarters
P.O. Box 7272
Kampala
-
Uganda
+256 (0)414 345 887
atalisuna@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.2
Study information
Scientific title
Comparison of quinine, artemether lumefantrine and dihydroartemisinin piperaquine for retreatment of recurrent malaria in Ugandan children
Acronym
Study hypothesis
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
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)
Study design
Nested phase IV, randomised, single blinded, multi-arm clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
01/12/2007
Overall trial end date
01/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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 guardians willingness and ability to comply with the study protocol for the duration of the trial
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
260
Participant 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
Recruitment start date
01/12/2007
Recruitment end date
01/12/2008
Locations
Countries of recruitment
Uganda
Trial participating centre
Epidemiology and Surveillance Division
Kampala
-
Uganda
Sponsor information
Organisation
Uganda Malaria Surveillance Project (Uganda)
Sponsor details
P.O. Box 7475
Kampala
-
Uganda
+256 (0)414 530 692
ctugaineyo@muucsf.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Department for International Development (DFID) (UK) - through Malaria Consortium (ref: SUBK026(2))
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23349741
Publication citations
-
Results
Yeka A, Tibenderana J, Achan J, D'Alessandro U, Talisuna AO, Efficacy of quinine, artemether-lumefantrine and dihydroartemisinin-piperaquine as rescue treatment for uncomplicated malaria in Ugandan children., PLoS ONE, 2013, 8, 1, e53772, doi: 10.1371/journal.pone.0053772.