Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo (Net-PBO)

Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo

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.

Study Overview

• Status: Unknown
• Conditions: Insecticide Resistance
• Intervention / Treatment: Drug: Pyrethroids; Drug: synergistic combination of insecticides

• Study Type: Interventional
• Enrollment (Anticipated): 1680
• Phase: Phase 4

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kongo-Central
    • Kisantu, Kongo-Central, Congo, The Democratic Republic of the
      • Hôpital Général de Référence Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria : -households where there are one or more children below the age of 10 years;

• 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)

Exclusion Criteria :

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The arm will receive bednets treated with conventional insecticide (Pyrethroid)	Drug: Pyrethroids; Conventional insecticide
Experimental: Experimental; The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides)	Drug: synergistic combination of insecticides; third generation insecticide -treated bednets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Lubumbashi
• Collaborators: Centers for Disease Control and Prevention; Universiteit Antwerpen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: synergistic combination; insecticide resistance; vectors
• Other Study ID Numbers: NET-06-08-76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No