MalariaComplianceNCT00873938
Compliance to Artesunate-Amodiaquine Therapy for Uncomplicated Malaria in Rural Ghana
An observational study of Malaria, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Malaria
- How many people
- 411 participants
- Where
- 1 siteGhana
- Study dates
- Oct 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A rural population in the middle belt of Ghana
Who may be able to join
- 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)
Who cannot join
- Pregnant women.
- Children ten years and below (to be catered for in the child antimalarial efficacy studies mentioned above).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary objective:
- To determine compliance to artesunate-amodiaquine therapy among patients diagnosed with acute uncomplicated malaria in the Kintampo District Hospital.
Secondary objectives:
- To determine patients compliance to each of the two drugs (artesunate or amodiaquine )
- To determine reasons for differential compliance to either of the two drugs (artesunate or amodiaquine).
- To determine patients perception and acceptance of artesunate-amodiaquine therapy for acute uncomplicated malaria.
- To determine the effect of compliance of artesunate-amodiaquine therapy on clinical and parasitological improvement in acute uncomplicated malaria.
Study design: The study will be a pragmatic randomized control trial. Patients will be recruited based on an inclusion criteria stated below. Baseline clinical symptoms of malaria and presence of malaria parasite (Plasmodium falciparum) in the blood of eligible patients reporting sick at the health facility would be determined. Study patients would be randomized into one of two groups, intervention and control groups.
Intervention:
The intervention refers to supervisory home visits by a trained community volunteer to ensure that paticipants comply to treatment during the artesunate-amodiaquine therapy. Supervisory home visits by a trained community volunteer form a major component of the Community Health Planning and Services programme being implemented by the Ghana Health Service. The intervention group would be supervised during artesunate-amodiaquine therapy and the control group would not be supervised during artesunate-amodiaquine therapy. The primary and secondary outcome measures below will be determined and compared among the intervention and control group
Primary outcome measure:
The main outcome is compliance to artesunate-amodiaquine combination therapy. It is defined as no artesunate or amodiaquine left on the fourth day after start of treatment of a malaria episode. This would be assessed by the investigators direct observation of the blister package of artesunate-Amodiaquine tablets.
Secondary outcome measures:
- Reasons for non-compliance would be determined by response of study participants. Care-takers of children below 18 years will answer on behalf of their children with the child's assent.
- Participants' perception and acceptance of supervision: It would be assessed by responses given by study participants in an indepth interview.
- Parasite clearance rates on day 14 and 28 i.e. the proportion of study participants in each group with P. falciparum parasiteamia at day 14 and 28 determined by blood smear microscopy.
- Clinical cure rates by days 14 and 28 i.e. the proportion of study participants in each group with symptoms of malaria on days 14 and 28 determined by a structured questionnaire at these times.
- Conditions
- Malaria
- Keywords
- Artesunate-Amodiaquine, Compliance, Malaria
- Medical subject headings
- Malaria, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1-supervised | Not described | |
| 2 -unsupervised | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is compliance to artesunate-amodiaquine combination therapy
Measured: Within first three days after diagnosis of malaria
Secondary outcomes (3)
Reasons for non-compliance
Measured: Within 28 days after diagnosis of malaria
Participants' perception and acceptance of supervision
Measured: Within 28 days after diagnosis of malaria
Parasite clearance rates on day 14 and 28
Measured: Within 28 days after diagnosis of malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintampo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Investigators
- Seth Owusu-Agyei, PhD, Principal investigator, Kintampo Health Research Centre, GhanaKwaku P Asante, MD, MPH, Principal investigator, Kintampo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873938
- Sponsor's protocol ID
- 2004/GD/70
- Acronym
- Compliance
- Status last verified
- Apr 2009
- First submitted
- 31 Mar 2009
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to Artesunate-Amodiaquine Therapy for Uncomplicated Malaria in Rural Ghana
- ClinicalTrials.gov ID
- NCT00873938
- Acronym / sponsor ID
- Compliance / 2004/GD/70
- Conditions
- Malaria
- Keywords
- Artesunate-Amodiaquine, Compliance, Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective:
- To determine compliance to artesunate-amodiaquine therapy among patients diagnosed with acute uncomplicated malaria in the Kintampo District Hospital.
Secondary objectives:
- To determine patients compliance to each of the two drugs (artesunate or amodiaquine )
- To determine reasons for differential compliance to either of the two drugs (artesunate or amodiaquine).
- To determine patients perception and acceptance of artesunate-amodiaquine therapy for acute uncomplicated malaria.
- To determine the effect of compliance of artesunate-amodiaquine therapy on clinical and parasitological improvement in acute uncomplicated malaria.
Study design: The study will be a pragmatic randomized control trial. Patients will be recruited based on an inclusion criteria stated below. Baseline clinical symptoms of malaria and presence of malaria parasite (Plasmodium falciparum) in the blood of eligible patients reporting sick at the health facility would be determined. Study patients would be randomized into one of two groups, intervention and control groups.
Intervention:
The intervention refers to supervisory home visits by a trained community volunteer to ensure that paticipants comply to treatment during the artesunate-amodiaquine therapy. Supervisory home visits by a trained community volunteer form a major component of the Community Health Planning and Services programme being implemented by the Ghana Health Service. The intervention group would be supervised during artesunate-amodiaquine therapy and the control group would not be supervised during artesunate-amodiaquine therapy. The primary and secondary outcome measures below will be determined and compared among the intervention and control group
Primary outcome measure:
The main outcome is compliance to artesunate-amodiaquine combination therapy. It is defined as no artesunate or amodiaquine left on the fourth day after start of treatment of a malaria episode. This would be assessed by the investigators direct observation of the blister package of artesunate-Amodiaquine tablets.
Secondary outcome measures:
- Reasons for non-compliance would be determined by response of study participants. Care-takers of children below 18 years will answer on behalf of their children with the child's assent.
- Participants' perception and acceptance of supervision: It would be assessed by responses given by study participants in an indepth interview.
- Parasite clearance rates on day 14 and 28 i.e. the proportion of study participants in each group with P. falciparum parasiteamia at day 14 and 28 determined by blood smear microscopy.
- Clinical cure rates by days 14 and 28 i.e. the proportion of study participants in each group with symptoms of malaria on days 14 and 28 determined by a structured questionnaire at these times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-supervised | – | – |
| 2 -unsupervised | – | – |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A rural population in the middle belt of Ghana
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women.
- Children ten years and below (to be catered for in the child antimalarial efficacy studies mentioned above).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main outcome is compliance to artesunate-amodiaquine combination therapy
Time frame: Within first three days after diagnosis of malaria
3 secondary outcomes
Reasons for non-compliance
Time frame: Within 28 days after diagnosis of malaria
Participants' perception and acceptance of supervision
Time frame: Within 28 days after diagnosis of malaria
Parasite clearance rates on day 14 and 28
Time frame: Within 28 days after diagnosis of malaria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
- Institutional Website, Kintampo Health Research CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Owusu-Agyei, PhD principal investigator
Kintampo Health Research Centre, Ghana
Kwaku P Asante, MD, MPH principal investigator
Kintampo Health Research Centre, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome is compliance to artesunate-amodiaquine combination therapy (time frame: Within first three days after diagnosis of malaria). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2010.