Trial | NCT01065116  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    coartem lumefantrine ...

  • Study Participants

    920
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.
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 Started
Mar 31
2010
Primary Completion
Nov 30
2010
Study Completion
Nov 30
2010
Last Update
Jul 21
2011
Estimate

Drug AL Blister-packs with Instruction leaflets

AL Blister packs with instruction leaflets will be dispensed

  • Other names: Coartem Blister 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

AL Blister-pack Experimental

AL unit dose age specific pre-packs Active Comparator

Criteria 

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
No Results Posted