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Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

NCT ID: NCT00238017

Last Updated: 2006-02-02

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.

Detailed Description

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Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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amodiaquine-artesunate versus amodiaquine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients aged 6 to 59 months
* Body weight \>5 kg
* Uncomplicated Plasmodium falciparum malaria
* Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
* Axillary temperature ≥37.5°C
* Ability to tolerate oral therapy
* Informed consent by the legal representative of the subject
* Residence in study area

Exclusion Criteria

* Previous participation in this clinical trial
* Haemoglobin \<5 mg/dl
* Mixed plasmodial infection
* Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
* Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response
* History of allergy or intolerance against study medications
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University for Development Studies, Tamale, Ghana

OTHER

Sponsor Role collaborator

Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Rowland N Otchwemah, PhD

Role: PRINCIPAL_INVESTIGATOR

University for Development Studies

Frank P Mockenhaupt, MD

Role: PRINCIPAL_INVESTIGATOR

Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany

Seth Owusu-Agyei, PhD

Role: PRINCIPAL_INVESTIGATOR

Kintampo Health Research Centre, Ghana

Locations

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University for Development Studies

Tamale, Northern Region, Ghana

Site Status

Countries

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Ghana

Other Identifiers

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A50068

Identifier Type: -

Identifier Source: secondary_id

NP05-M4

Identifier Type: -

Identifier Source: org_study_id