Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
Primary Purpose
Malaria
Status
Completed
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
AL Blister-packs with Instruction leaflets
AL unit dose age specific pre-packs
Sponsored by
About this trial
This is an interventional treatment trial for Malaria focused on measuring Malaria
Eligibility 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
Sites / Locations
- Mulanda Health centre IV
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AL Blister-pack
AL unit dose age specific pre-packs
Arm Description
Outcomes
Primary Outcome Measures
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
Secondary Outcome Measures
Parasitological cure rates
Clinical cure rates
Full Information
NCT ID
NCT01065116
First Posted
February 8, 2010
Last Updated
July 20, 2011
Sponsor
Malaria Consortium, Uganda
Collaborators
Ministry of Health, Uganda, Makerere University
1. Study Identification
Unique Protocol Identification Number
NCT01065116
Brief Title
Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
Official Title
Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Malaria Consortium, Uganda
Collaborators
Ministry of Health, Uganda, Makerere University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
920 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL Blister-pack
Arm Type
Experimental
Arm Title
AL unit dose age specific pre-packs
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AL Blister-packs with Instruction leaflets
Other Intervention Name(s)
Coartem Blister packs
Intervention Description
AL Blister packs with instruction leaflets will be dispensed
Intervention Type
Drug
Intervention Name(s)
AL unit dose age specific pre-packs
Other Intervention Name(s)
Coartem pre-packs
Intervention Description
Age specific colour coded Unit dose pre-packs will be used
Primary Outcome Measure Information:
Title
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Parasitological cure rates
Time Frame
Day 28
Title
Clinical cure rates
Time Frame
Days 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaniter I Nankabirwa, MSc CEB
Organizational Affiliation
Makerere University Kampala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulanda Health centre IV
City
Tororo District
ZIP/Postal Code
256
Country
Uganda
12. IPD Sharing Statement
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Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
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