Insecticide Resistance Clinical Trial
— Net-PBOOfficial 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
| Verified date | April 2018 |
| Source | Université de Lubumbashi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1680 |
| Est. completion date | September 2019 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 10 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Congo, The Democratic Republic of the | Hôpital Général de Référence Saint Luc | Kisantu | Kongo-Central |
| Lead Sponsor | Collaborator |
|---|---|
| Université de Lubumbashi | Centers for Disease Control and Prevention, Universiteit Antwerpen |
Congo, The Democratic Republic of the,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Sporozoite rate | Sporozoite detection by ELISA to determine infectivity of anopheles | Anopheles mosquitoes will be captured every 3 months during 1 year |