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Clinical Trials/PACTR201611001859416
PACTR201611001859416
Completed
N/A

A randomised controlled trial to investigate the efficacy, safety and tolerability of adding a single low primaquine dose to artemether-lumefantrine for the treatment of symptomatic uncomplicated Plasmodium falciparum malaria

niversity of Cape Town0 sites140 target enrollmentNovember 11, 2016
ConditionsMalaria

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malaria
Sponsor
niversity of Cape Town
Enrollment
140
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 11, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Cape Town

Eligibility Criteria

Inclusion Criteria

  • Plasmodium falciparum positive by RDT
  • Age \> 2 years
  • Weight over 10 kg
  • Prescribed artemether\-lumefantrine according to standard practice
  • Informed consent (by legally acceptable representative if under 18 years of age)
  • Assent in children aged 7 and above
  • Intention to remain in the study area for the duration of the follow\-up period

Exclusion Criteria

  • Evidence of severe illness/ danger signs
  • Known allergy to study medications
  • Medical history of haemolysis, rheumatoid arthritis, lupus erythematosus or cardiac disease
  • In patients receiving concurrently other drugs that are cause hemolysis, bone marrow suppression or QTc interval prolongation
  • Hb \< 7 g/dL
  • A decrease in Hb of \> 2 g/dL between day 0 and day 3 prior to primaquine dose
  • Currently menstruating
  • Pregnant or breastfeeding
  • History of any antimalarials (including primaquine) taken within the last 4 weeks
  • Blood transfusion within the last 90 days

Outcomes

Primary Outcomes

Not specified

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