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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065116
• Other study ID #: COMDIS -Blisterpack
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: July 20, 2011
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: May 2010
• Source: Malaria Consortium, Uganda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• AL Blister-packs with Instruction leaflets
AL Blister packs with instruction leaflets will be dispensed
• AL unit dose age specific pre-packs
Age specific colour coded Unit dose pre-packs will be used

Locations

Country	Name	City	State
Uganda	Mulanda Health centre IV	Tororo District

Sponsors (3)

Lead Sponsor	Collaborator
Malaria Consortium, Uganda	Makerere University, Ministry of Health, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.		Day 3	Yes
Secondary	Parasitological cure rates		Day 28	Yes
Secondary	Clinical cure rates		Days 3	Yes