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

Study Overview
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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.

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

Official Title
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Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda

Conditions
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Malaria

Intervention / Treatment
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* Drug: AL Blister-packs with Instruction leaflets
* Drug: AL unit dose age specific pre-packs


Participation Criteria
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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 Exclusion Criteria: Features of life threatening illness including severe malaria

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL Blister-pack<br> | Drug: AL Blister-packs with Instruction leaflets<br>* AL Blister packs with instruction leaflets will be dispensed<br>* Other names: Coartem Blister packs;|
| Active Comparator: AL unit dose age specific pre-packs<br> | Drug: AL unit dose age specific pre-packs<br>* Age specific colour coded Unit dose pre-packs will be used<br>* Other names: Coartem pre-packs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report. |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasitological cure rates |  | Day 28 | 
| Clinical cure rates |  | Days 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria