MalariaINDIE-1bNCT04053907
P. Falciparum Infection Dynamics and Transmission to Inform Elimination
A study testing Community Case Management, Weekly fever screening and treatment and Monthly malaria screening in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Community Case Management, Weekly fever screening and treatment and Monthly malaria screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteThe Gambia
- Study dates
- 15 Aug 2019to 31 May 2022
- Phase
- Interventional
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident in the village.
- Willingness to participate in repeated assessments of health and infection status and to donate a maximum of 30 mL (milliliter) of blood (children <5 years of age), 37 mL (milliliter) of blood (children <10 years of age) or 52 mL (milliliter) of blood (older individuals) during an 18-month period.
Who cannot join
- Any chronic illness that would affect study participation.
- Pre-existing severe chronic health conditions
- History of intolerance to artemether-lumefantrine.
- Participants < 6months old and pregnant women in the first trimester (only for Arm with MDA-DP treatment).
- Hypersensitivity to DP (only for Arm with MDA-DP treatment).
- Taking drugs that influence cardiac function or prolong QTcorrected interval (only for Arm with MDA-DP treatment).
Trial locations and contacts
1 site in 1 country.
The Gambia1 site, 1 recruiting
- Recruiting
Medical research Council Unit The Gambia at LSHTM
Basse Santa Su
Umberto D'Alessandro, PhD, MD, (+220) 449-5442, udalessandro@mrc.gm
About this study
In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.
Read the detailed description
In the current study, the investigators will first improve access to care in all villages by implementing community-based clinical case management (CCM) (year 1). In this year, the investigators will quantify gametocyte carriage and transmission from clinical cases passively recruited by CCM, and gametocyte carriage and transmission from asymptomatic infections detected in community surveys. These data will support the interpretation of the main study outcomes in year 2 when the investigators will directly compare the effect of CCM on the human reservoir of infection as compared to three different approaches, namely i) active fever screening and treatment that should detect symptomatic infections for early treatment; ii) Mass Screening and Treatment (MSAT) that will systematically screen, using point-of-care diagnostics, the whole population, with infected individuals immediately treated; and iii) mass drug administration (MDA) that will treat the whole population with a full course of an antimalarial treatment.
- Conditions
- Malaria
- Being tested
- Community Case Management, Weekly fever screening and treatment, Monthly malaria screening, MDA
- Keywords
- falciparum, gametocyte, elimination, anopheles, transmission, diagnostic
- Medical subject headings
- Malaria, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Case ManagementOther
Community Case Management (CCM), consisting of community health workers able to diagnose malaria by standard RDTs and treating positive individuals with artemether-lumefantrine (AL), according to national guidelines.
Weekly fever screening and treatmentOther
Consists of weekly visits by trained VHW who will screen for fever by taking the axillary temperature. If the body temperature is ≥37.5°C, a standard RDT will be performed and, if positive, the individual will be treated with AL, according to national guidelines.
Monthly malaria screeningOther
CCM plus monthly screening of the whole population with high sensitive RDT (HS-RDT); positive individuals will be treated with AL regardless of symptoms (MSAT).
MDAOther
CCM plus 3 monthly rounds of MDA with dihydroartemisinin-piperaquine (DP) starting during the dry season, before the malaria transmission season starts.
| Study group | Role | What they receive |
|---|---|---|
| CCM:Standard of Care | No intervention | Community Case Management (CCM), with passively monitored malaria incidence by community health workers using standard RDTs and artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL) according to national guidelines. |
| CCM plus weekly fever screening and treatment | Experimental | CCM plus active case detection (ACD) by fever screening and treatment if positive. Trained village health workers (VHW) recruited for this study will carry out weekly visits of all residents and screen for fever using research-grade thermometers. A standard RDT will be performed in all individuals with a body temperature ≥37.5°C or with reported fever in the last 24 hours. RDT positive individuals will be treated with AL according to national guidelines. Receives: Other: Community Case Management; Other: Weekly fever screening and treatment |
| CCM plus MSAT | Experimental | CCM plus monthly screening for malaria infection and treatment of positive individuals, regardless of symptoms. Screening will be performed by research staff and timed to ensure a gap of 25-35 days between screening rounds; Positive individuals will be treated with AL, according to national guidelines. Receives: Other: Community Case Management; Other: Monthly malaria screening |
| CCM plus dry season MDA | Experimental | CCM plus plus 3 monthly rounds of MDA with a long-acting ACT (dihydroartemisinin-piperaquine, DP) starting in the dry season (April, May, June) (tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight). Receives: Other: Community Case Management; Other: MDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite prevalence by molecular detection at the end of study (cross-sectional survey).
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2.
Measured: 16 weeks
Parasite density by molecular detection at the end of study (cross-sectional survey).
The primary outcome measure is parasite density (parasite/µL) in the cross-sectional survey conducted at the end of the transmission season of year 2.
Measured: 16 weeks
Secondary outcomes (6)
Gametocyte prevalence by molecular methods at the end of study (cross-sectional survey).
Gametocyte prevalence in quantitative polymerase chain reaction (qPCR) detected infections is assessed by molecular methods and compared between arms.
Measured: 16 weeks
Gametocyte density by molecular methods at the end of study (cross-sectional survey).
Gametocyte density (gametocytes/µL) in qPCR detected infections is assessed by molecular methods and compared between arms.
Measured: 16 weeks
Gametocyte prevalence of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.
Gametocyte prevalence of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Measured: Throughout study, an average of 18 months
Gametocyte density of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Measured: Throughout study, an average of 18 months
Incidence of malaria infections
Regular visits by weekly active case detection and monthly screening will result in the identification of malaria infections that are not detected during CCM. Number of infections detected in each arm will be quantified and compared between arms.
Measured: Throughout study, an average of 18 months
Infectivity of P. falciparum infections to mosquitoes
For a selection of infections, infectiousness to mosquitoes is assessed by membrane feeding assays.
Measured: Throughout study, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start15 Aug 2019
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, National Malaria Control Programme, The Gambia, Radboud University Medical Center, University of California, San Francisco, Institute for Disease Modeling
- Responsible party
- Sponsor
- Investigators
- Chris Drakeley, PhD, Principal investigator, London School Hygiene and Tropical medicineUmberto D'Alessandro, PhD, MD, Principal investigator, MRC Unit The Gambia @ LSHTMTeun Bousema, PhD, Principal investigator, Radboud University Medical Centre, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053907
- Sponsor's protocol ID
- 16642
- Other IDs
- OPP1173572
- Acronym
- INDIE-1b
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised individual participant data may be shared on a digital repository or upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P. Falciparum Infection Dynamics and Transmission to Inform Elimination
- ClinicalTrials.gov ID
- NCT04053907
- Acronym / sponsor ID
- INDIE-1b / 16642
- Conditions
- Malaria
- Keywords
- falciparum, gametocyte, elimination, anopheles, transmission, diagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, National Malaria Control Programme, The Gambia, Radboud University Medical Center, University of California, San Francisco, Institute for Disease Modeling
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 13 Aug 2019 (actual)
- 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.
In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.
Detailed description
In the current study, the investigators will first improve access to care in all villages by implementing community-based clinical case management (CCM) (year 1). In this year, the investigators will quantify gametocyte carriage and transmission from clinical cases passively recruited by CCM, and gametocyte carriage and transmission from asymptomatic infections detected in community surveys. These data will support the interpretation of the main study outcomes in year 2 when the investigators will directly compare the effect of CCM on the human reservoir of infection as compared to three different approaches, namely i) active fever screening and treatment that should detect symptomatic infections for early treatment; ii) Mass Screening and Treatment (MSAT) that will systematically screen, using point-of-care diagnostics, the whole population, with infected individuals immediately treated; and iii) mass drug administration (MDA) that will treat the whole population with a full course of an antimalarial treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CCM:Standard of Care | No intervention | –Community Case Management (CCM), with passively monitored malaria incidence by community health workers using standard RDTs and artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL) according to national guidelines. |
| CCM plus weekly fever screening and treatment | Experimental | Other: Community Case Management, Other: Weekly fever screening and treatmentCCM plus active case detection (ACD) by fever screening and treatment if positive. Trained village health workers (VHW) recruited for this study will carry out weekly visits of all residents and screen for fever using research-grade thermometers. A standard RDT will be performed in all individuals with a body temperature ≥37.5°C or with reported fever in the last 24 hours. RDT positive individuals will be treated with AL according to national guidelines. |
| CCM plus MSAT | Experimental | Other: Community Case Management, Other: Monthly malaria screeningCCM plus monthly screening for malaria infection and treatment of positive individuals, regardless of symptoms. Screening will be performed by research staff and timed to ensure a gap of 25-35 days between screening rounds; Positive individuals will be treated with AL, according to national guidelines. |
| CCM plus dry season MDA | Experimental | Other: Community Case Management, Other: MDACCM plus plus 3 monthly rounds of MDA with a long-acting ACT (dihydroartemisinin-piperaquine, DP) starting in the dry season (April, May, June) (tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight). |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Resident in the village.
- Willingness to participate in repeated assessments of health and infection status and to donate a maximum of 30 mL (milliliter) of blood (children <5 years of age), 37 mL (milliliter) of blood (children <10 years of age) or 52 mL (milliliter) of blood (older individuals) during an 18-month period.
Key exclusion criteria (6 listed)
- Any chronic illness that would affect study participation.
- Pre-existing severe chronic health conditions
- History of intolerance to artemether-lumefantrine.
- Participants < 6months old and pregnant women in the first trimester (only for Arm with MDA-DP treatment).
- Hypersensitivity to DP (only for Arm with MDA-DP treatment).
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 |
|---|---|---|
| Community Case ManagementCommunity Case Management (CCM), consisting of community health workers able to diagnose malaria by standard RDTs and treating positive individuals with artemether-lumefantrine (AL), according to national guidelines. | Other | CCM plus MSAT, CCM plus dry season MDA, CCM plus weekly fever screening and treatment |
| Weekly fever screening and treatmentConsists of weekly visits by trained VHW who will screen for fever by taking the axillary temperature. If the body temperature is ≥37.5°C, a standard RDT will be performed and, if positive, the individual will be treated with AL, according to national guidelines. | Other | CCM plus weekly fever screening and treatment |
| Monthly malaria screeningCCM plus monthly screening of the whole population with high sensitive RDT (HS-RDT); positive individuals will be treated with AL regardless of symptoms (MSAT). | Other | CCM plus MSAT |
| MDACCM plus 3 monthly rounds of MDA with dihydroartemisinin-piperaquine (DP) starting during the dry season, before the malaria transmission season starts. | Other | CCM plus dry season MDA |
Primary outcome
Parasite prevalence by molecular detection at the end of study (cross-sectional survey).
Time frame: 16 weeks
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2.
Parasite density by molecular detection at the end of study (cross-sectional survey).
Time frame: 16 weeks
The primary outcome measure is parasite density (parasite/µL) in the cross-sectional survey conducted at the end of the transmission season of year 2.
6 secondary outcomes
Gametocyte prevalence by molecular methods at the end of study (cross-sectional survey).
Time frame: 16 weeks
Gametocyte density by molecular methods at the end of study (cross-sectional survey).
Time frame: 16 weeks
Gametocyte prevalence of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.
Time frame: Throughout study, an average of 18 months
Gametocyte density of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.
Time frame: Throughout study, an average of 18 months
Incidence of malaria infections
Time frame: Throughout study, an average of 18 months
Infectivity of P. falciparum infections to mosquitoes
Time frame: Throughout study, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided. Anonymised individual participant data may be shared on a digital repository or upon reasonable request.
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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.
Chris Drakeley, PhD principal investigator
London School Hygiene and Tropical medicine
Umberto D'Alessandro, PhD, MD principal investigator
MRC Unit The Gambia @ LSHTM
Teun Bousema, PhD principal investigator
Radboud University Medical Centre, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Case Management, Weekly fever screening and treatment and Monthly malaria screening in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 The Gambia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Drakeley, PhD (+44 (0)20 7927 2289, Chris.drakeley@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite prevalence by molecular detection at the end of study (cross-sectional survey). (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 31 Mar 2022.