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Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania (C3)

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
artemether-lumefantrine
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, Plasmodium falciparum, artemether-lumefantrine, effectiveness

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kibaha District

Outcomes

Primary Outcome Measures

Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
during 42 days follow-up.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2007
Last Updated
October 24, 2007
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00454961
Brief Title
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Plasmodium falciparum, artemether-lumefantrine, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
artemether-lumefantrine
Primary Outcome Measure Information:
Title
Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
Title
during 42 days follow-up.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Björkman, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kibaha District
City
Kibaha
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
21410954
Citation
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.
Results Reference
derived

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

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