MalariaPhase 4RDT-ACTNCT00832754
Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial
A Phase 4 study testing RDT and Clinical Judgement as basis for treatment of malaria with ACT in people with Malaria, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
Trial summary
Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. Read more about this study
- Who is it for?
- Ages Up to 48 months
- Conditions the study is for
- Malaria
- What is being tested?
- RDT and Clinical Judgement as basis for treatment of malaria with ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,063 participants
- Where
- 1 siteGhana
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 4
- 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 Up to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children aged less than 48mths reporting to health center with suspected malaria
Who cannot join
- Children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Restricting the Use of AS-AQ Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial
Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in <48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.
Read the detailed description
Two-stage, four component study Stage I - Component A: Accuracy of RDT and the outcome of treatment based on RDT results Primary outcome:What is the sensitivity and specificity of Paracheck cassettes in Ghana to diagnose malaria?
Stage 1 - Component B: delivery system determinants of effective RDT based ACT Primary outcome: What are the delivery system determinants of effective RDT based ACT?
Stage 2 - Component A: effects of restricted use of ACTs based on RDT results: a randomised controlled trial Primary outcome: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children
Stage 2 - component B: Cost effectiveness analysis:
Primary outcome:What is the cost effectiveness of RDT based ACT for treatment of children under 4 years compared with ACT based on clinical judgement?
- Conditions
- Malaria
- Being tested
- RDT, Clinical Judgement as basis for treatment of malaria with ACT
- Keywords
- malaria, rapid diagnostic test, artemisinin, Ghana
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDTDevice
Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.
Clinical Judgement as basis for treatment of malaria with ACTOther
Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.
| Study group | Role | What they receive |
|---|---|---|
| RDT+ACT group | Experimental | RDT+ACT group (ACT offered to RDT positive cases only) Receives: Device: RDT; Other: Clinical Judgement as basis for treatment of malaria with ACT |
| Clinical judgement+ACT group | Active comparator | Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement) Receives: Device: RDT; Other: Clinical Judgement as basis for treatment of malaria with ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)
Measured: Three years
Secondary outcomes (1)
Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,063 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
- Frank E Baiden, Principal investigator, Kintampo Health Research CenterJayne Webster, Principal investigator, London School of Hygiene and Tropical MedicineChristopher Whitty, Principal investigator, London School of Hygiene and Tropical MedicineSeth Owusu-Agyei, Principal investigator, Kintampo Health Research CenterDaniel Chandramohan, Principal investigator, London School of Hygiene and Tropical MedicineJane Bruce, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832754
- Sponsor's protocol ID
- KHRC1
- Acronym
- RDT-ACT
- Status last verified
- Dec 2012
- First submitted
- 29 Jan 2009
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tawiah T, Hansen KS, Baiden F, Bruce J, Tivura M, Delimini R, Amengo-Etego S, Chandramohan D, Owusu-Agyei S, Webster J. Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana. PLoS One. 2016 Oct 3;11(10):e0164055. doi: 10.1371/journal.pone.0164055. eCollection 2016.
PubMed 27695130Baiden F, Bruce J, Webster J, Tivura M, Delmini R, Amengo-Etego S, Owusu-Agyei S, Chandramohan D. Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial. PLoS One. 2016 Apr 7;11(4):e0152960. doi: 10.1371/journal.pone.0152960. eCollection 2016.
PubMed 27055275Baiden F, Webster J, Tivura M, Delimini R, Berko Y, Amenga-Etego S, Agyeman-Budu A, Karikari AB, Bruce J, Owusu-Agyei S, Chandramohan D. Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS One. 2012;7(4):e34073. doi: 10.1371/journal.pone.0034073. Epub 2012 Apr 13.
PubMed 22514617
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Restricting the Use of AS-AQ Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial
- ClinicalTrials.gov ID
- NCT00832754
- Acronym / sponsor ID
- RDT-ACT / KHRC1
- Conditions
- Malaria
- Keywords
- malaria, rapid diagnostic test, artemisinin, Ghana
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,063 participants (actual)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Mar 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 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.
Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in <48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.
Detailed description
Two-stage, four component study Stage I - Component A: Accuracy of RDT and the outcome of treatment based on RDT results Primary outcome:What is the sensitivity and specificity of Paracheck cassettes in Ghana to diagnose malaria?
Stage 1 - Component B: delivery system determinants of effective RDT based ACT Primary outcome: What are the delivery system determinants of effective RDT based ACT?
Stage 2 - Component A: effects of restricted use of ACTs based on RDT results: a randomised controlled trial Primary outcome: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children
Stage 2 - component B: Cost effectiveness analysis:
Primary outcome:What is the cost effectiveness of RDT based ACT for treatment of children under 4 years compared with ACT based on clinical judgement?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDT+ACT group | Experimental | Device: RDT, Other: Clinical Judgement as basis for treatment of malaria with ACTRDT+ACT group (ACT offered to RDT positive cases only) |
| Clinical judgement+ACT group | Active comparator | Device: RDT, Other: Clinical Judgement as basis for treatment of malaria with ACTClinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement) |
Who may qualify
- Ages
- Up to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children aged less than 48mths reporting to health center with suspected malaria
Key exclusion criteria (1 listed)
- Children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDTStudy children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ. | Device | Clinical judgement+ACT group, RDT+ACT group |
| Clinical Judgement as basis for treatment of malaria with ACTStudy children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ. | Other | Clinical judgement+ACT group, RDT+ACT group |
Primary outcome
Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)
Time frame: Three years
1 secondary outcome
Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children
Time frame: Three years
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 21 Dec 2012.
- Derived from this study: PubMed 27695130Tawiah T, Hansen KS, Baiden F, Bruce J, Tivura M, Delimini R, Amengo-Etego S, Chandramohan D, Owusu-Agyei S, Webster J. Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana. PLoS One. 2016 Oct 3;11(10):e0164055. doi: 10.1371/journal.pone.0164055. eCollection 2016.
- Derived from this study: PubMed 27055275Baiden F, Bruce J, Webster J, Tivura M, Delmini R, Amengo-Etego S, Owusu-Agyei S, Chandramohan D. Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial. PLoS One. 2016 Apr 7;11(4):e0152960. doi: 10.1371/journal.pone.0152960. eCollection 2016.
- Derived from this study: PubMed 22514617Baiden F, Webster J, Tivura M, Delimini R, Berko Y, Amenga-Etego S, Agyeman-Budu A, Karikari AB, Bruce J, Owusu-Agyei S, Chandramohan D. Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS One. 2012;7(4):e34073. doi: 10.1371/journal.pone.0034073. Epub 2012 Apr 13.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Frank E Baiden principal investigator
Kintampo Health Research Center
Jayne Webster principal investigator
London School of Hygiene and Tropical Medicine
Christopher Whitty principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RDT and Clinical Judgement as basis for treatment of malaria with ACT in people with 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 1 inclusion and 1 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 21 Dec 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832754, which also lists 3 linked publications.
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 21 Dec 2012.