Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya

Malaria Clinical Trial

— SR-M-KEN  

Official title:

Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02294201
• Other study ID #: SR-M-KEN
• Status: Withdrawn
• Phase: N/A
• First received: November 17, 2014
• Last updated: October 5, 2016
• Start date: June 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of spatial repellent products in reducing the incidence of malaria infection in human cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between intervention and control arms.

Description:

The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR). This measure will inform PE (the reduction of incidence) between intervention and control study arms using the formula: PE =[(Ip - Ia)/Ip]* 100%; based on an expected minimum effect size of 30%. First time infections in these subjects will offer relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The primary entomological endpoint will be adult densities of vector species via human-landing catch (HLC) from sentinel households from intervention and control arms over the follow-up period.

Secondary epidemiological endpoints will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by microscopy and the total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects). Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity and species-specific effects of the spatial repellent product.

Both epidemiological and entomological endpoints will be utilized to look at the relationship between SR and PE based on product coverage (to include diversion and community effects) and insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints (epidemiological and entomological) over transmission seasons will also be investigated by using the cumulative incidence of infection over the season and applying a survival curve analysis of the cohort data.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Children aged 6-59 months

• glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines

• Hb > 5mg/dl

• Temperature =38.0°C) and no moderate or severe acute illness/infection on the day of inclusion

• Sleeps in cluster >90% of nights during any given month

• No plans for extended travel (<1month) outside of home during study

• Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial

• Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

Exclusion Criteria:

• children < 6 months or > 5 years

• G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines

• Severe anemia

• Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of inclusion

• Sleeps in cluster <90% of nights during any given month

• Plans for extended travel (>1month) outside of home during study

• Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial

• No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• Spatial Repellent product with active ingredient
Spatial Repellent product
• Active ingredient
Transfluthrin (Active ingredient)
• Spatial Repellent product without active ingredient (SHIELD)
Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson

Locations

Country	Name	City	State
Kenya	Kemri-Crc	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
University of Notre Dame	Centers for Disease Control and Prevention, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malaria Incidence	Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR	104 weeks	No