Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
No.187/RNEC/2010
Study information
Scientific title
An open labeled randomised trial of Coartem vs. Co-Arinate for uncomplicated malaria and parasite carriage in Rwanda
Acronym
CoCo Trial
Study hypothesis
Coarinate is as effective as coartem
Ethics approval
The Rwanda National Ethics Committee approved on the 31st of March 2010 (ref: No.187 /RNEC / 2010)
Study design
Open label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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 names
Coartem, coarnate
Primary outcome measures
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).
Secondary outcome measures
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
Overall trial start date
15/09/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Either sex, age > 6 months
2. Simple malaria
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
900
Participant exclusion criteria
Severe malaria
Recruitment start date
15/09/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Rwanda
Trial participating centre
Kigali University Teaching Hospital
Kigali
655
Rwanda
Funders
Funder type
Research organisation
Funder name
INTERACT (Rwanda)
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
Results - basic reporting
Publication summary