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

ISRCTN	ISRCTN99046537
DOI	https://doi.org/10.1186/ISRCTN99046537
Protocol serial number	1.2
Sponsor	Uganda Malaria Surveillance Project (Uganda)
Funder	Department for International Development (DFID) (UK) - through Malaria Consortium (ref: SUBK026(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

Primary study design	Interventional
Study design	Nested phase IV, randomised, single blinded, multi-arm clinical trial
Secondary study design	Randomised controlled trial
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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DP), quinine, chlorproguanil hydrochloride-dapsone-artesunate (CDA)
Primary outcome measure(s)	1. Polymerase chain reaction (PCR) unadjusted treatment failure up to day 28 2. PCR adjusted treatment failure up to day 28
Key secondary outcome measure(s)	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
Completion date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	5 Years
Sex	All
Target sample size at registration	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 guardians 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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/11/2013		Yes	No