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

Phase 3

Completed

• Conditions: Malaria
• Interventions: Drug: AL Blister-packs with Instruction leaflets; Drug: AL unit dose age specific pre-packs

• Registration Number: NCT01065116
• Lead Sponsor: Malaria Consortium, Uganda

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-03
• Status Verified: 2010-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL Blister-pack	AL Blister-packs with Instruction leaflets	-
AL unit dose age specific pre-packs	AL unit dose age specific pre-packs	-

Primary Outcome Measures

Name	Time	Method
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.	Day 3

Secondary Outcome Measures

Name	Time	Method
Parasitological cure rates	Day 28
Clinical cure rates	Days 3

Trial Locations

Locations (1)

Mulanda Health centre IV; 🇺🇬 Tororo District, Uganda