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

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ClinicalTrials.gov Identifier: NCT03289663
Recruitment Status : Active, not recruiting
First Posted : September 21, 2017
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
Universiteit Antwerpen
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Gillon Ilombe Kaounga, Ministry of Public Health, Democratic Republic of the Congo

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.


Condition or disease Intervention/treatment Phase
Insecticide Resistance Drug: synergistic combination of insecticides Drug: Pyrethroids Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized trial
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

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




Primary Outcome Measures :
  1. Incidence rate of laboratory confirmed clinical cases of Malaria [ Time Frame: 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 ]
    Microscopy to confirm the diagnosis of Malaria

  2. Sporozoite rate [ Time Frame: Anopheles mosquitoes will be captured every 3 months during 1 year ]
    Sporozoite detection by ELISA to determine infectivity of anopheles



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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289663


Locations
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Congo, The Democratic Republic of the
Hôpital Général de Référence Saint Luc
Kisantu, Kongo-Central, Congo, The Democratic Republic of the
Sponsors and Collaborators
Université de Lubumbashi
Universiteit Antwerpen
Centers for Disease Control and Prevention

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Responsible Party: Gillon Ilombe Kaounga, Researcher, Ministry of Public Health, Democratic Republic of the Congo
ClinicalTrials.gov Identifier: NCT03289663     History of Changes
Other Study ID Numbers: NET-06-08-76
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Gillon Ilombe Kaounga, Ministry of Public Health, Democratic Republic of the Congo:
synergistic combination
insecticide resistance
vectors