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Completed

NCT Number: NCT00454961

Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.

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Key information

Conditions

Malaria Infections Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kibaha District

Kibaha, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged <5 years
  • Weight >5 kg
  • Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
  • Having a history of fever in the preceding 24 h
  • Able to ingest tablets orally
  • Willing and able to attend stipulated follow-up visits
  • With written informed consent from parent/guardian for children to participate in the trial.

Exclusion criteria

Presenting with any of the following "danger signs of severe malaria":

  • Convulsions (>1 episode within previous 24 hours)
  • Lethargic/unconscious

Treatment and study plan

Artemether-lumefantrine

Drug

Primary outcomes

  1. Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine

  2. during 42 days follow-up.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania

Acronym: C3

Important dates

Study start
2007
First posted
Apr 2, 2007
Registry last updated
Oct 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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