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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065116

Enrollment

920

Registered

2010-02-09

Start date

2010-03-31

Completion date

2010-11-30

Last updated

2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria

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

Interventions

DRUGAL Blister-packs with Instruction leaflets

AL Blister packs with instruction leaflets will be dispensed

DRUGAL unit dose age specific pre-packs

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Months to 7 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Parasitological cure rates	Day 28
Clinical cure rates	Days 3

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026