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Clinical Trials/ISRCTN71912942
ISRCTN71912942
Completed
Not Applicable

Assessment of first line therapy for uncomplicated falciparum malaria with artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) in Bobo-Dioulasso, Burkina Faso: a randomised controlled trial

Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)0 sites197 target enrollmentJune 28, 2010
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)
Enrollment
197
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 28, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)

Eligibility Criteria

Inclusion Criteria

  • •1\. Not previously enrolled in this study
  • •2\. Both males and females, aged greater than 6 months
  • •3\. Weight greater than 5 kg
  • •4\. Fever (greater than 37\.5ºC axillary) or history of fever in the previous 24 hours
  • •5\. Absence of any history of serious side effects to study medications
  • •6\. No evidence of a concomitant febrile illness in addition to malaria
  • •7\. Provision of informed consent and ability to participate in 28\-day follow\-up (patient has easy access to health unit)
  • •8\. No danger signs or evidence of severe malaria defined as:
  • •8\.1\. Unarousable coma (if after convulsion, greater than 30 minutes)
  • •8\.2\. Repeated convulsions (greater than two within 24 hours)

Exclusion Criteria

  • •1\. Severe malaria
  • •2\. Unable to comply with planned follow up
  • •3\. Pregnancy

Outcomes

Primary Outcomes

Not specified

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