Condition category
Infections and Infestations
Date applied
23/08/2010
Date assigned
25/10/2010
Last edited
25/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Rulisa

ORCID ID

Contact details

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

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

Sponsor information

Organisation

INTERACT - Centre for Poverty related Communicable Diseases (CPCD) (Rwanda)

Sponsor details

Boulevard de la revolution
Kigali
00
Rwanda

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes