Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
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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.
Condition | Intervention | Phase |
---|---|---|
Malaria |
Drug: AL Blister-packs with Instruction leaflets Drug: AL unit dose age specific pre-packs |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda |
- Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report. [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
- Parasitological cure rates [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
- Clinical cure rates [ Time Frame: Days 3 ] [ Designated as safety issue: Yes ]
Enrollment: | 920 |
Study Start Date: | March 2010 |
Study Completion Date: | November 2010 |
Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: AL Blister-pack |
Drug: AL Blister-packs with Instruction leaflets
AL Blister packs with instruction leaflets will be dispensed
Other Name: Coartem Blister packs
|
Active Comparator: AL unit dose age specific pre-packs |
Drug: AL unit dose age specific pre-packs
Age specific colour coded Unit dose pre-packs will be used
Other Name: Coartem 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
Ages Eligible for Study: | 4 Months to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Uganda | |
Mulanda Health centre IV | |
Tororo District, Uganda, 256 |
Principal Investigator: | Joaniter I Nankabirwa, MSc CEB | Makerere University Kampala |
No publications provided
Responsible Party: | Nankabirwa Joaniter, Makerere University Kampala |
ClinicalTrials.gov Identifier: | NCT01065116 History of Changes |
Other Study ID Numbers: | COMDIS -Blisterpack |
Study First Received: | February 8, 2010 |
Last Updated: | July 20, 2011 |
Health Authority: | Uganda: National Council for Science and Technology |
Keywords provided by Malaria Consortium, Uganda:
Malaria |
Additional relevant MeSH terms:
Malaria Protozoan Infections Parasitic Diseases Artemether Lumefantrine Artemether-lumefantrine combination Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics |
ClinicalTrials.gov processed this record on October 17, 2012