NCT01065116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 21, 2011

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

February 8, 2010

Last Update Submit

July 20, 2011

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

  • Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.

    Day 3

Secondary Outcomes (2)

  • Parasitological cure rates

    Day 28

  • Clinical cure rates

    Days 3

Study Arms (2)

AL Blister-pack

EXPERIMENTAL
Drug: AL Blister-packs with Instruction leaflets

AL unit dose age specific pre-packs

ACTIVE COMPARATOR
Drug: AL unit dose age specific pre-packs

Interventions

AL Blister-packs with Instruction leafletsDRUG

AL Blister packs with instruction leaflets will be dispensed

Also known as: Coartem Blister packs
AL Blister-pack
AL unit dose age specific pre-packsDRUG

Age specific colour coded Unit dose pre-packs will be used

Also known as: Coartem pre-packs
AL unit dose age specific pre-packs

Eligibility Criteria

Age4 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Features of life threatening illness including severe malaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulanda Health centre IV

Tororo District, Uganda, 256, Uganda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Joaniter I Nankabirwa, MSc CEB

    Makerere University Kampala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 21, 2011

Record last verified: 2010-05

Locations

UG(1)