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

July 20, 2011 updated by: Malaria Consortium, Uganda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

920

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Tororo District, Uganda, 256
        • Mulanda Health Centre IV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL Blister-pack
Drug: AL Blister-packs with Instruction leaflets
AL Blister packs with instruction leaflets will be dispensed
Other Names:
  • Coartem Blister packs
Active Comparator: AL unit dose age specific pre-packs
Drug: AL unit dose age specific pre-packs
Age specific colour coded Unit dose pre-packs will be used
Other Names:
  • Coartem pre-packs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Parasitological cure rates
Time Frame: Day 28
Day 28
Clinical cure rates
Time Frame: Days 3
Days 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaria Consortium, Uganda

Collaborators

Makerere University
Ministry of Health, Uganda

Investigators

  • Principal Investigator: Joaniter I Nankabirwa, MSc CEB, Makerere University Kampala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMDIS -Blisterpack

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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