NCT03289663

Brief Summary

Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool. The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,680

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

August 10, 2017

Last Update Submit

April 9, 2018

Conditions

Insecticide Resistance

Keywords

synergistic combinationinsecticide resistancevectors

Outcome Measures

Primary Outcomes (2)

  • Incidence rate of laboratory confirmed clinical cases of Malaria

    Microscopy to confirm the diagnosis of Malaria

    Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation

  • Sporozoite rate

    Sporozoite detection by ELISA to determine infectivity of anopheles

    Anopheles mosquitoes will be captured every 3 months during 1 year

Study Arms (2)

Control

ACTIVE COMPARATOR

The arm will receive bednets treated with conventional insecticide (Pyrethroid)

Drug: Pyrethroids

Experimental

EXPERIMENTAL

The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides)

Drug: synergistic combination of insecticides

Interventions

synergistic combination of insecticidesDRUG

third generation insecticide -treated bednets

Experimental
PyrethroidsDRUG

Conventional insecticide

Control

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ability and willingness of the head of the household to participate based on signed informed consent (or fingerprint) and with the assistance of an impartial witness (if the head of the household is illiterate)

You may not qualify if:

  • refusal of the head of household to participate
  • known allergy to insecticides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Général de Référence Saint Luc

Kisantu, Bas-Congo Province, Democratic Republic of the Congo

Location

Related Publications (1)

  • Gleave K, Lissenden N, Chaplin M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2021 May 24;5(5):CD012776. doi: 10.1002/14651858.CD012776.pub3.

    PMID: 34027998DERIVED

MeSH Terms

Interventions

Pyrethrins

Intervention Hierarchy (Ancestors)

Cyclopentane MonoterpenesMonoterpenesTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The 2 groups of villages will randomly receive either the bednets treated with conventional insecticide (Pyrethroid) or the synergistic combination of insecticides. None of the groups knows which bednets they receive.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 10, 2017

First Posted

September 21, 2017

Study Start

October 2, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

DE(1)