Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690841
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-01-09
Brief Title:
FocaL Mass Drug Administration for Vivax Malaria Elimination
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
FocaL Mass Drug Administration for Vivax Malaria Elimination FLAME a Pragmatic Cluster Randomized Controlled Trial in Peru
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAME
Brief Summary:
FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration fMDA to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru Standard interventions including symptomatic and asymptomatic screening for malaria infections provision of insecticide-treated bednets and environmental transmission monitoring will be compared to clusters of villages randomized to receive anti-malarial drugs
Detailed Description:
This trial trial is an open-label cluster-randomized controlled trial in Loreto Region Peru a low transmission setting ie anual incidence 2501000 where the unit of randomization is a village or cluster There will be two study arms Control and fMDA Villages will receive fMDA or control based on a restricted randomization that includes baseline factors such as incidence distance to a health post and population
The interventions for both control and fMDA clusters will include standard interventions high coverage of vector control passive and active symptomatic case management and RACD of asymptomatic cases The intervention will take place in 2 rounds two months apart for three cycles each cycle separated by regular intervals of 9-11 months fMDA will target high-risk villagers individuals residing in households that are within 200 meters of a Pv index case households from the prior 2 years High-risk status will be determined in each survey before the administration of Round a of fMDA Pv index cases refers to confirmed Pv cases reported by the health system
In each cycle of fMDA the 1st round will include 3 days of chloroquine CQ for treatment of Pv asexual blood stages with TQ for Pv liver stages With a prolonged half-life up to 15 days and post-treatment effect observed up to 77 days TQ will also have a prophylactic and likely gametocytocidal effect for Pv and Pf For continued anti-relapse prophylactic and transmission-blocking effects a follow-up round 2 months after each 1st round will include TQ with single-dose CQ sdCQ If TQ but not PQ is contraindicated a standard 7-day PQ course will be used CQ including in a single dose will potentiate the anti-relapse effect of PQ and likely TQ Preliminary data from the study area shows that 32 of the study population is 16 years old and will receive PQ However the investigators do not anticipate this to influence the impact of the fMDA due to our use of directly observed therapy DOT If pediatric TQ is approved for use in Peru during the study an addendum to the protocol will be presented for approval by the IRB and INS and incorporated into the study
An end-line survey will be carried out at the end of the 3-year trial intervention period An interim survey will also be conducted in a subset of the population both arms In each of these surveys a dried blood spot will be collected from all participants Anyone with fever in the prior 48 hours and a positive blood smear from a local health post will receive treatment per national policy Anyone with fever in the prior 48 hours without a positive blood smear will be encouraged to go to a health post To maximize public health relevance the trial will be pragmatic and implemented through the existing health system
The primary research objectives are
1 To determine the effectiveness of three rounds of fMDA to reduce Pv transmission in the Loreto Department Peru compared to standard interventions
2 To evaluate the safety and tolerability of fMDA by measuring incidence of severe adverse events or severe malaria in the treatment arm
3 To measure the cost-effectiveness and acceptability of fMDA by calculating the cost per malaria case averted for intervention and control arms
The interventions for both control and fMDA clusters will include standard interventions high coverage of vector control passive and active symptomatic case management and RACD of asymptomatic cases The intervention will take place in 2 rounds two months apart for three cycles each cycle separated by regular intervals of 9-11 months fMDA will target high-risk villagers individuals residing in households that are within 200 meters of a Pv index case households from the prior 2 years High-risk status will be determined in each survey before the administration of Round a of fMDA Pv index cases refers to confirmed Pv cases reported by the health system
In each cycle of fMDA the 1st round will include 3 days of chloroquine CQ for treatment of Pv asexual blood stages with TQ for Pv liver stages With a prolonged half-life up to 15 days and post-treatment effect observed up to 77 days TQ will also have a prophylactic and likely gametocytocidal effect for Pv and Pf For continued anti-relapse prophylactic and transmission-blocking effects a follow-up round 2 months after each 1st round will include TQ with single-dose CQ sdCQ If TQ but not PQ is contraindicated a standard 7-day PQ course will be used CQ including in a single dose will potentiate the anti-relapse effect of PQ and likely TQ Preliminary data from the study area shows that 32 of the study population is 16 years old and will receive PQ However the investigators do not anticipate this to influence the impact of the fMDA due to our use of directly observed therapy DOT If pediatric TQ is approved for use in Peru during the study an addendum to the protocol will be presented for approval by the IRB and INS and incorporated into the study
An end-line survey will be carried out at the end of the 3-year trial intervention period An interim survey will also be conducted in a subset of the population both arms In each of these surveys a dried blood spot will be collected from all participants Anyone with fever in the prior 48 hours and a positive blood smear from a local health post will receive treatment per national policy Anyone with fever in the prior 48 hours without a positive blood smear will be encouraged to go to a health post To maximize public health relevance the trial will be pragmatic and implemented through the existing health system
The primary research objectives are
1 To determine the effectiveness of three rounds of fMDA to reduce Pv transmission in the Loreto Department Peru compared to standard interventions
2 To evaluate the safety and tolerability of fMDA by measuring incidence of severe adverse events or severe malaria in the treatment arm
3 To measure the cost-effectiveness and acceptability of fMDA by calculating the cost per malaria case averted for intervention and control arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-0008 | OTHER | UCSF IRB | httpsreporternihgovquickSearch1U01AI157962 |
| 1U01AI157962 | NIH | None | None |