NCT00873938

Brief Summary

With a change in malaria treatment policy to use combination antimalaria therapy, it is envisaged that compliance to combination therapy would be less than that of monotherapy that was being used for case management in Ghana. This is especially so as amodiaquine is unpopular because of its side-effects and the combination therapy is not a single formulation (fixed dose). Compliance may further be enhanced by community supervision through home visits of combination antimalarial therapy in cases of uncomplicated malaria. This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological cure rates. This study targeting age groups above ten years, would complement a child artesunate -amodiaquine efficacy study being undertaken by the same investigators in children ten years and below at Kintampo District at the same time. The funding for the child study has been approved by the Gates Malaria Partnership. Findings from both studies, involving all age groups would be made available to the National Malaria Control Programme and other stakeholders as practical information that may be beneficial to implementing policy change process from antimalarial monotherapy to a combination therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
Last Updated

April 30, 2010

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

March 31, 2009

Last Update Submit

April 29, 2010

Conditions

Malaria

Keywords

Artesunate-AmodiaquineComplianceMalaria

Outcome Measures

Primary Outcomes (1)

  • The main outcome is compliance to artesunate-amodiaquine combination therapy

    Within first three days after diagnosis of malaria

Secondary Outcomes (3)

  • Reasons for non-compliance

    Within 28 days after diagnosis of malaria

  • Participants' perception and acceptance of supervision

    Within 28 days after diagnosis of malaria

  • Parasite clearance rates on day 14 and 28

    Within 28 days after diagnosis of malaria

Study Arms (2)

1-supervised

2 -unsupervised

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A rural population in the middle belt of Ghana

You may qualify if:

  • Male and female patients aged above ten years reporting at the Kintampo district hospital.
  • Diagnosed as having Plasmodium falciparum uncomplicated malaria.
  • Axillary temperature ≥37.5oC but less than 40 oC or history of fever in preceding 24 hr.
  • Ability to tolerate oral therapy.
  • Patient who live and can be located in the Kintampo District.
  • Consent of patient and/or care giver (in the case of children)

You may not qualify if:

  • Pregnant women.
  • Children ten years and below (to be catered for in the child antimalarial efficacy studies mentioned above).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kintampo Health Research Centre

Brong Ahafo Region, Kintampo, Ghana

Location

Related Links

MeSH Terms

Conditions

MalariaPatient Compliance

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Seth Owusu-Agyei, PhD

    Kintampo Health Research Centre, Ghana

    PRINCIPAL INVESTIGATOR

  • Kwaku P Asante, MD, MPH

    Kintampo Health Research Centre, Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

October 1, 2005

Primary Completion

July 1, 2006

Study Completion

September 1, 2006

Last Updated

April 30, 2010

Record last verified: 2009-04

Locations

GH(1)