Status:

COMPLETED

Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping

Lead Sponsor:

Karolinska University Hospital

Collaborating Sponsors:

Muhimbili University of Health and Allied Sciences

Conditions:

Malaria

Eligibility:

All Genders

1-10 years

Phase:

PHASE4

Brief Summary

The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms ...

Eligibility Criteria

Inclusion

  • Age 1-10 years
  • Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
  • No general danger signs or severe malaria present
  • Haemoglobin ≥70 g/L
  • History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
  • No other cause of fever is detectable
  • No severe malnutrition
  • Guardian/patient has understood the procedures of the study and willing to participate

Exclusion

  • Not able to drink or breastfeed
  • Vomiting everything
  • Recent history of convulsions
  • Lethargic or unconscious
  • Unable to sit or stand (as appropriate for age)
  • History of allergy to test drugs
  • History of intake of any drugs other than paracetamol and aspirin within 3 days
  • Symptoms/signs of severe malaria

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2006

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00336375

Start Date

June 1 2006

End Date

July 1 2006

Last Update

November 1 2007

Active Locations (1)

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Fukayosi Primary Health Care Center

Fukayosi, Bagamoyo District, Tanzania

Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping | DecenTrialz