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

NCT00454961 | Completed Phase 4

• 1 other identifier: CCC-2007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Malaria; Plasmodium falciparum; artemether-lumefantrine; effectiveness

Outcome Measures

Primary Outcomes (2)

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

• during 42 days follow-up.

Interventions

artemether-lumefantrine DRUG

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Presenting with any of the following "danger signs of severe malaria":
• Convulsions (\>1 episode within previous 24 hours)
• Lethargic/unconscious

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Kibaha District

Kibaha, Tanzania

Location

Related Publications (1)

• Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Martensson A. Effectiveness of artemether-lumefantrine provided by community health workers in under-five children with uncomplicated malaria in rural Tanzania: an open label prospective study. Malar J. 2011 Mar 16;10:64. doi: 10.1186/1475-2875-10-64.

  PMID: 21410954 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Anders Björkman, Professor

  Karolinska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2007
• First Posted: April 2, 2007
• Study Start: April 1, 2007
• Last Updated: October 25, 2007

Record last verified: 2007-10

Locations

TA (1)