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Completed

NCT Number: NCT01065116

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

4 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mulanda Health centre IV

Tororo District, Uganda, 256

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AL Blister-packs with Instruction leaflets

Drug

AL Blister packs with instruction leaflets will be dispensed

Other names: Coartem Blister packs

AL unit dose age specific pre-packs

Drug

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

Other names: Coartem pre-packs

Primary outcomes

  1. Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.

    Time frame: Day 3

Secondary outcomes

  1. Parasitological cure rates

    Time frame: Day 28

  2. Clinical cure rates

    Time frame: Days 3

Sponsors and collaborators

Lead sponsor

Malaria Consortium, Uganda

Other

Collaborators

  • Makerere University
  • Ministry of Health, Uganda

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2010
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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