Coartem or Coarnate for uncomplicated malaria and parasite carriage in Rwanda

ISRCTN	ISRCTN91805477
DOI	https://doi.org/10.1186/ISRCTN91805477
Protocol serial number	No.187/RNEC/2010
Sponsor	INTERACT - Centre for Poverty related Communicable Diseases (CPCD) (Rwanda)
Funder	INTERACT (Rwanda)

Submission date: 23/08/2010
Registration date: 25/10/2010
Last edited: 25/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Rulisa
Scientific

Kigali University Teaching Hospital
Department of Clinical research
BP 655
Kigali
655
Rwanda

Study information

Primary study design	Interventional
Study design	Open label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An open labeled randomised trial of Coartem vs. Co-Arinate for uncomplicated malaria and parasite carriage in Rwanda
Study acronym	CoCo Trial
Study objectives	Coarinate is as effective as coartem
Ethics approval(s)	The Rwanda National Ethics Committee approved on the 31st of March 2010 (ref: No.187 /RNEC / 2010)
Health condition(s) or problem(s) studied	Malaria
Intervention	Patients will be randomised to receive 1. Coartem (arthemeter lumifantrine) 5-14 kg 20 mg arthemeter+120 mg lumefantrine 2/day for 3 days 15-24 kg: 40 mg arthemeter+ 240 mg lumefantrine 2/day for 3 days 25-34 kg: 60 mg arthemeter+360 mg lumefantrine 2/day for 3 days 34+ kg: 80 mg arthemeter + 480 mg lumefantirne 2/day for 3 days 2. Co-arinate (artesunate + sulfamethoxypyrazine + pyrimethamine) 5-14 kg: 50 mg artesunate+125mg sulfamethoxypyrazine+6.25mg pyrimethamine (t=0 and12 and 24 hrs later) 15-25 kg: 100 mg artesunate+250mg sulfamethoxypyrazine+12.5 mg pyrimethamine (t=0 and 12 and 24 hrs later) 25-34 kg: 150 mg artesunate+ 375 mg sulfamethoxypyrazine+ 18.75 mg pyrimethamine (t=0 and 12 and 24 hrs later) 35+ kg: 200 mg artesunate+500 mg sulfamethoxypyrazine+25 mg pyrimethamine (t=0 and 12 and 24 hrs later) All drugs will be given orally. Follow-up of all participants will be at day 0, day 1, day 7, day 14, day 21, day 28, day 35 and day 42.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Coartem, coarnate
Primary outcome measure(s)	Parasite clearance as per WHO guidelines: Full parasitological an clinical responses after 42 days of follow-up as measured by microscopy examination. At every follow-up visit a microscopy slide will be examined for parasites and counted against 200 whole blood count (WBC).
Key secondary outcome measure(s)	Gametocyte carriage: At day 0,day 1, day 7 and day 14 blood samples (50 ul on filter paper) will be collected for molecular analysis of gametocytes. After nucleic acid extraction analysis will be done with NASBA and results will be expressed as gametocytes/ul
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	Not Specified
Target sample size at registration	900
Key inclusion criteria	1. Either sex, age > 6 months 2. Simple malaria
Key exclusion criteria	Severe malaria
Date of first enrolment	15/09/2010
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Rwanda

Study participating centre

Kigali University Teaching Hospital

Kigali
655
Rwanda

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes