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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Keywords

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Malaria Plasmodium falciparum artemether-lumefantrine effectiveness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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artemether-lumefantrine

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Björkman, Professor

Role: STUDY_DIRECTOR

Karolinska University Hospital

Locations

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Kibaha District

Kibaha, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED

PMID: 21410954 (View on PubMed)

Other Identifiers

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CCC-2007

Identifier Type: -

Identifier Source: org_study_id