Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs

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

PHASE3

Total Enrollment

920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

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Detailed Description

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Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector

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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AL Blister-pack

Group Type EXPERIMENTAL

AL Blister-packs with Instruction leaflets

Intervention Type DRUG

AL Blister packs with instruction leaflets will be dispensed

AL unit dose age specific pre-packs

Group Type ACTIVE_COMPARATOR

AL unit dose age specific pre-packs

Intervention Type DRUG

Age specific colour coded Unit dose pre-packs will be used

Interventions

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AL Blister-packs with Instruction leaflets

AL Blister packs with instruction leaflets will be dispensed

Intervention Type DRUG

AL unit dose age specific pre-packs

Age specific colour coded Unit dose pre-packs will be used

Intervention Type DRUG

Other Intervention Names

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Coartem Blister packs Coartem pre-packs

Eligibility Criteria

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Inclusion Criteria

* Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
* Weight between 5 kg and 25 kg
* Positive malaria smear results for P. falciparum
* No history of intake of AL in the preceding two weeks
* Able to tolerate oral therapy
* Caregiver has given written informed consent to participate in the study
* If they reside within the designated catchment area of the health facility