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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Uganda
Makerere University
Information provided by:
Malaria Consortium, Uganda
ClinicalTrials.gov Identifier:
NCT01065116
First received: February 8, 2010
Last updated: July 20, 2011
Last verified: May 2010
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Malaria Consortium, Uganda:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   4 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065116

Locations
Uganda
Mulanda Health centre IV
Tororo District, Uganda, 256
Sponsors and Collaborators
Malaria Consortium, Uganda
Ministry of Health, Uganda
Makerere University
Investigators
Principal Investigator: Joaniter I Nankabirwa, MSc CEB Makerere University Kampala
  More Information

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 July 20, 2014