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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065116
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : July 21, 2011
Ministry of Health, Uganda
Makerere University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Malaria Drug: AL Blister-packs with Instruction leaflets Drug: AL unit dose age specific pre-packs Phase 3

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  (Clinical Trial)
Actual Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
Study Start Date : March 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: AL Blister-pack Drug: AL Blister-packs with Instruction leaflets
AL Blister packs with instruction leaflets will be dispensed
Other Name: 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 Name: Coartem pre-packs

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

Secondary Outcome Measures :
  1. Parasitological cure rates [ Time Frame: Day 28 ]
  2. Clinical cure rates [ Time Frame: Days 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065116

Mulanda Health centre IV
Tororo District, Uganda, 256
Sponsors and Collaborators
Malaria Consortium, Uganda
Ministry of Health, Uganda
Makerere University
Principal Investigator: Joaniter I Nankabirwa, MSc CEB Makerere University Kampala

Responsible Party: Nankabirwa Joaniter, Makerere University Kampala Identifier: NCT01065116     History of Changes
Other Study ID Numbers: COMDIS -Blisterpack
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: May 2010

Keywords provided by Malaria Consortium, Uganda:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents