MalariaPhase 4CORE ZambiaNCT02654912
Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration
A Phase 4 study testing Reactive Focal Drug Administration in people with Malaria, run by PATH at 1 site in Zambia.
Trial summary
This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through… Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Reactive Focal Drug Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,682 participants
- Where
- 1 siteZambia
- Study dates
- Feb 2016to Jul 2020
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- anyone not excluded and consenting
Who cannot join
- contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin
- anyone seriously ill
- currently taking antimalarial medicines
- allergy to artemisinin drugs
- pregnant women in first trimester
- children under 3 months of age
- reported heart condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-led Responses for Elimination (CoRE): A Cluster Randomized Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration in Malaria Elimination Areas in Southern Province Zambia
This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.
Read the detailed description
The study is a cluster randomized controlled trial designed to evaluate the impact of RFDA intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. It will be conducted among a background population of ~130,000 people in ~30,000 households in 16 health center catchment areas across several districts in Southern Province. The government of Zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination.
The secondary objectives of the study include: 1). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities; 2). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community; 4). Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.
- Conditions
- Malaria
- Being tested
- Reactive Focal Drug Administration
- Keywords
- malaria, elimination, surveillance and response, dihydroartemisinin+piperaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive Focal Drug AdministrationDrug
This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).
| Study group | Role | What they receive |
|---|---|---|
| Reactive Focal Drug Administration | Experimental | This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP). Receives: Drug: Reactive Focal Drug Administration |
| Reactive Focal Test and Treat | No intervention | This is the current standard of care in Southern Province and is described by a reactive response to passively detected index case of malaria. The reactive response consists of testing all individuals within a defined radius of each RDT-confirmed incident malaria case with an RDT and treating all positive individuals with artemether-lumefantrine (AL). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria seropositivity in children under five
Malaria seropositivity in children under five after two-year intervention within health center catchment areas
Measured: 24 months
Secondary outcomes (2)
Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers
Quality-improved incidence of malaria data confirmed by malaria rapid diagnostic test (RDT) or microscopy as measured through passive case detection at health posts and health centers in the study area.
Measured: 24 months
PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months
Polymerase Chain Reaction (PCR)-based testing for malaria parasite prevalence of individuals participating in each community at 0, 30 and 90 days following a reactive research response for a period of 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia, AKROS Global Health
- Responsible party
- Sponsor
- Investigators
- Daniel Bridges, PhD, Principal investigator, Akros
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654912
- Sponsor's protocol ID
- PATH-WIRB-1155095
- Acronym
- CORE Zambia
- Status last verified
- Sep 2020
- First submitted
- 12 Nov 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee R, Silumbe K, Nyangu J, Larsen DA. Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia. Trials. 2017 Nov 2;18(1):511. doi: 10.1186/s13063-017-2249-0.
PubMed 29096671Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee RW, Mambwe B, Mulube C, Wu L, Tetteh KKA, Drakeley C, Chishimba S, Mwenda M, Silumbe K, Larsen DA. Reactive focal drug administration associated with decreased malaria transmission in an elimination setting: Serological evidence from the cluster-randomized CoRE study. PLOS Glob Public Health. 2022 Dec 5;2(12):e0001295. doi: 10.1371/journal.pgph.0001295. eCollection 2022.
PubMed 36962857
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-led Responses for Elimination (CoRE): A Cluster Randomized Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration in Malaria Elimination Areas in Southern Province Zambia
- ClinicalTrials.gov ID
- NCT02654912
- Acronym / sponsor ID
- CORE Zambia / PATH-WIRB-1155095
- Conditions
- Malaria
- Keywords
- malaria, elimination, surveillance and response, dihydroartemisinin+piperaquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,682 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ministry of Health, Zambia, AKROS Global Health
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 13 Jan 2016 (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.
This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.
Detailed description
The study is a cluster randomized controlled trial designed to evaluate the impact of RFDA intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. It will be conducted among a background population of ~130,000 people in ~30,000 households in 16 health center catchment areas across several districts in Southern Province. The government of Zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination.
The secondary objectives of the study include: 1). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities; 2). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community; 4). Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive Focal Drug Administration | Experimental | Drug: Reactive Focal Drug AdministrationThis is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP). |
| Reactive Focal Test and Treat | No intervention | –This is the current standard of care in Southern Province and is described by a reactive response to passively detected index case of malaria. The reactive response consists of testing all individuals within a defined radius of each RDT-confirmed incident malaria case with an RDT and treating all positive individuals with artemether-lumefantrine (AL). |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- anyone not excluded and consenting
Key exclusion criteria (7 listed)
- contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin
- anyone seriously ill
- currently taking antimalarial medicines
- allergy to artemisinin drugs
- pregnant women in first trimester
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 |
|---|---|---|
| Reactive Focal Drug AdministrationThis is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP). | Drug | Reactive Focal Drug Administration |
Primary outcome
Malaria seropositivity in children under five
Time frame: 24 months
Malaria seropositivity in children under five after two-year intervention within health center catchment areas
2 secondary outcomes
Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers
Time frame: 24 months
PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months
Time frame: 24 months
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 4 Feb 2021.
- Background: PubMed 29096671Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee R, Silumbe K, Nyangu J, Larsen DA. Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia. Trials. 2017 Nov 2;18(1):511. doi: 10.1186/s13063-017-2249-0.
- Derived from this study: PubMed 36962857Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee RW, Mambwe B, Mulube C, Wu L, Tetteh KKA, Drakeley C, Chishimba S, Mwenda M, Silumbe K, Larsen DA. Reactive focal drug administration associated with decreased malaria transmission in an elimination setting: Serological evidence from the cluster-randomized CoRE study. PLOS Glob Public Health. 2022 Dec 5;2(12):e0001295. doi: 10.1371/journal.pgph.0001295. eCollection 2022.
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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.
Daniel Bridges, PhD principal investigator
Akros
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 Reactive Focal Drug Administration in people with Malaria, run by PATH at 1 site in Zambia.
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 7 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 4 Feb 2021. 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 Zambia. 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?
Malaria seropositivity in children under five (time frame: 24 months). 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 NCT02654912, which also lists 2 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 4 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.