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

M

Malaria Consortium, Uganda

Status and phase

Completed
Phase 3

Conditions

Malaria

Treatments

Drug: AL Blister-packs with Instruction leaflets
Drug: AL unit dose age specific pre-packs

Study type

Interventional

Funder types

Other

Identifiers

NCT01065116
COMDIS -Blisterpack

Details and patient eligibility

About

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.

Full 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

Enrollment

920 patients

Sex

All

Ages

4 months to 7 years old

Volunteers

No 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

Trial design

920 participants in 2 patient groups

AL Blister-pack
Experimental group
Treatment:
Drug: AL Blister-packs with Instruction leaflets
AL unit dose age specific pre-packs
Active Comparator group
Treatment:
Drug: AL unit dose age specific pre-packs

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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