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

Malaria Clinical Trial

— C3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454961
• Other study ID #: CCC-2007
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2007
• Last updated: October 24, 2007
• Start date: April 2007

Study information

• Verified date: October 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

1. Aged <5 years

2. Weight >5 kg

3. 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

4. Having a history of fever in the preceding 24 h

5. Able to ingest tablets orally

6. Willing and able to attend stipulated follow-up visits

7. 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":

1. Convulsions (>1 episode within previous 24 hours)

2. Lethargic/unconscious

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• artemether-lumefantrine

Locations

Country	Name	City	State
Tanzania	Kibaha District	Kibaha

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
Primary	during 42 days follow-up.