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Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping

NCT ID: NCT00336375

Last Updated: 2007-11-01

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

All treatment doses accompanied with intake of fatty food

Group Type EXPERIMENTAL

artemether-lumefantrine

Intervention Type DRUG

All treatment doses given either accompanied or not-accompanied with intake of fatty food.

2

All treatment doses not-accompanied with intake of fatty food.

Group Type ACTIVE_COMPARATOR

artemether-lumefantrine

Intervention Type DRUG

All treatment doses given either accompanied or not-accompanied with intake of fatty food.

Interventions

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artemether-lumefantrine

All treatment doses given either accompanied or not-accompanied with intake of fatty food.

Intervention Type DRUG

Other Intervention Names

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All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food

Eligibility Criteria

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Inclusion Criteria

* Age 1-10 years
* Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
* No general danger signs or severe malaria present
* Haemoglobin ≥70 g/L
* History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
* No other cause of fever is detectable
* No severe malnutrition
* Guardian/patient has understood the procedures of the study and willing to participate

Exclusion Criteria

* Not able to drink or breastfeed
* Vomiting everything
* Recent history of convulsions
* Lethargic or unconscious
* Unable to sit or stand (as appropriate for age)
* History of allergy to test drugs
* History of intake of any drugs other than paracetamol and aspirin within 3 days
* Symptoms/signs of severe malaria
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Anders Bjorkman, Professor

Role: STUDY_DIRECTOR

Karolinska University Hospital

Locations

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Fukayosi Primary Health Care Center

Fukayosi, Bagamoyo District, Tanzania

Site Status

Countries

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Tanzania

References

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Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.

Reference Type DERIVED
PMID: 30860013 (View on PubMed)

Carlsson AM, Ngasala BE, Dahlstrom S, Membi C, Veiga IM, Rombo L, Abdulla S, Premji Z, Gil JP, Bjorkman A, Martensson A. Plasmodium falciparum population dynamics during the early phase of anti-malarial drug treatment in Tanzanian children with acute uncomplicated malaria. Malar J. 2011 Dec 20;10:380. doi: 10.1186/1475-2875-10-380.

Reference Type DERIVED
PMID: 22185672 (View on PubMed)

Other Identifiers

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04/04/2006

Identifier Type: -

Identifier Source: org_study_id