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Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi

NCT ID: NCT00164710

Last Updated: 2012-09-27

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

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-09-30

Brief Summary

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Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.

Detailed Description

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Conditions

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Malaria, Falciparum

Keywords

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antimalarials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sulfadoxine-pyrimethamine

Intervention Type DRUG

amodiaquine plus sulfadoxine-pyrimethamine

Intervention Type DRUG

amodiaquine plus artesunate

Intervention Type DRUG

chlorproguanil-dapsone plus artesunate

Intervention Type DRUG

lumefantrine-artemether

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children age 6 - 59 months
* Axillary temperature ≥ 37.5 °C
* Monoinfection with P. falciparum
* Parasitaemia between 2000 - 200000 parasites/µl
* Haemoglobin concentration (finger-prick blood sample by HemoCue) \> 7g/dl
* Consent by the patient's adult guardian
* Residence in the locality and willingness to attend for scheduled visits

Exclusion Criteria

* altered consciousness
* convulsions
* prostration (inability to sit/stand/suck/drink)
* respiratory distress or breathlessness
* jaundice
* abnormal breathing
* haemoglobinuria
* circulatory collapse
* persistent vomiting (cannot keep down liquids)
* evidence of a diagnosis other than malaria on physical examination
* presence of mixed infection
* presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia)
* contraindications to the antimalarial drugs used, especially history of allergy
* history of receiving a drug with antimalarial activity in the week prior to enrollment
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Population, Malawi

OTHER_GOV

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel N Bronzan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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Kawale Health Center

Lilongwe, Lilongwe District, Malawi

Site Status

Machinga District Hospital

Liwonde, Machinga District, Malawi

Site Status

Matiki Health Center

Dwangwa, Nkhotakota District, Malawi

Site Status

Countries

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Malawi

Other Identifiers

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PA# 04018

Identifier Type: -

Identifier Source: secondary_id

CDC-NCID-4539

Identifier Type: -

Identifier Source: org_study_id