Treatment of Non-falciparum Malaria

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-02-29

Brief Summary

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Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.

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Detailed Description

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Conditions

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Acute Non-falciparum Malaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

artemether-lumefantrine

Intervention Type DRUG

Standard artemether-lumefantrine treatment

Interventions

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artemether-lumefantrine

Standard artemether-lumefantrine treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
* Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density \> 50-200000/μl of blood
* Written informed consent

Exclusion Criteria

* Patients with presence of other clinical conditions requiring hospitalization
* Presence of other febrile conditions
* Presence of significant anemia, defined by hemoglobin \< 7g/dl
* Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
* Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
* Pregnant and breast feeding females

Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No