Coartem or Coarnate for uncomplicated malaria and parasite carriage in Rwanda
| ISRCTN | ISRCTN91805477 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91805477 |
| Secondary identifying numbers | No.187/RNEC/2010 |
- 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
Scientific
Kigali University Teaching Hospital
Department of Clinical research
BP 655
Kigali
655
Rwanda
Study information
| Study design | Open label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Coartem, coarnate |
| Primary outcome measure | 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 study start date | 15/09/2010 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Not Specified |
| Target number of participants | 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
655
Rwanda
Sponsor information
INTERACT - Centre for Poverty related Communicable Diseases (CPCD) (Rwanda)
Not defined
Not defined
Boulevard de la revolution
Kigali
00
Rwanda
Funders
Funder type
Research organisation
INTERACT (Rwanda)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
