Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia

Dengue Clinical Trial

— WMP-COL  

Official title:

World Mosquito Program - Colombia (WMP-COLOMBIA): The Impact of City-wide Deployment of Wolbachia-infected Mosquitoes on Arboviral Disease Incidence in Medellin and Bello, Colombia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631719
• Other study ID #: PEC004_18
• Secondary ID: PECET-002
• Status: Completed
• Start date: October 25, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Study setting: Medellin and Bello municipalities, Colombia Health condition(s) studied:

Dengue, Zika and chikungunya virus infection Intervention: Deployment of Wolbachia-infected Aedes aegypti mosquitoes in Medellin and Bello.

Study design:

1. An interrupted time-series analysis utilising routine disease surveillance data collected by the Medellín and Bello Health Secretariats, which aims to compare incidence of dengue, chikungunya and Zika pre- and post-Wolbachia release.

2. A test-negative study using an incident case-control design, which aims to quantify the reduction in disease incidence among people living within a Wolbachia-treated zone compared with an untreated zone that has a similar dengue risk profile at baseline.

Description:

• Selection and enrolment of participants: Enrolment of patients will commence after completion of Wolbachia releases in the early zones. Study processes for enrolling patients presenting with febrile illness will be established at a network of primary health care facilities that serve the population who reside in the study area. Trained research staff will be employed to assist with study processes in each site. Participants will be enrolled from within the population of patients (aged ≥3 years old) presenting with undifferentiated fever of 1-4 days' duration. All patients meeting the inclusion criteria will be eligible for enrolment and will be asked to provide written informed consent before participating in the study.

• Recruitment procedures: All eligible participants meeting study inclusion criteria will be invited to enroll continuously throughout the study period. Recruitment will occur during normal clinic hours. Participants will be managed according to standard clinical practice by the attending physicians. Recruitment rates in each clinic and across the study site as a whole will be monitored weekly, including a review of the screening logs to identify the proportion of eligible participants who did not consent to participate. The field coordinator will make regular visits to low-enrolling clinics to identify clinic-based, patient-based or other causes for low recruitment, and put measures in place to address these.

• Screening: All patients presenting with febrile illness will be screened against the study inclusion criteria by trained staff. All eligible febrile individuals will be recorded in a screening log and invited to participate. Participation status (consent/decline) will be recorded against each participant in the log.

• Informed consent: Written informed consent will be sought from participants (or their guardian where the participant is a minor) by trained local staff, after explaining the study objectives, processes, data, and sample collection, and the participant has had an opportunity to ask questions. A verbal explanation of the written Explanatory Statement will be provided to all participants in the local language. In addition, participants aged between 7 and 17 years will be invited to sign an assent form indicating they understand the research and agree to participate. Data and sample collection procedures

• Data collection: A unique identifier will be assigned to each participant at enrollment. Basic demographic details, eligibility against the inclusion criteria and illness onset date will be recorded in a standardized case report form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Fever (either self-reported or objectively measured, e.g. axillary temperature =38oC, with a date of onset between 1-4 days prior to the day of presentation.

• Aged =3 years old.

• Lived (i.e. slept) in the study area every night (or day) for the 10 days preceding illness onset.

Exclusion Criteria:

• Localising features suggestive of a specific diagnosis e.g. severe diarrhea, otitis, pneumonia

• Prior enrollment in the study within the previous 4 weeks.

Related Conditions & MeSH terms

• Arbovirus Infections
• Chikungunya Fever
• Chikungunya Virus Infection
• Communicable Diseases
• Dengue
• Infections
• Virus Diseases
• Zika Virus Infection

Intervention

Biological:
• Wolbachia-carrying Ae.aegypti mosquitoes
Wolbachia-infected Ae. aegypti mosquito eggs and adults sequentially deployed into Medellin and Bello, Colombia. Deployments cease once Wolbachia prevalence has reached a predetermined frequency (usually =60%).

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia	Medellín	Antioquia

Sponsors (5)

Lead Sponsor	Collaborator
Universidad de Antioquia	Bill and Melinda Gates Foundation, Monash University, United States Agency for International Development (USAID), Wellcome Trust

Country where clinical trial is conducted

Colombia, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dengue cases notified to surveillance system	Incidence of dengue cases (suspected, epidemiological link, and IgM positive for dengue) notified to the disease surveillance system	5 years
Primary	Virologically-confirmed dengue	Virologically-confirmed dengue virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as dengue cases if plasma samples collected 1-4 days after onset of fever test positive for dengue virus NS1 antigen or dengue virus nucleic acid by RT-qPCR.	2 years
Secondary	IgM test positive for dengue	Number of cases who were IgM test positive for dengue	5 years
Secondary	Severe dengue cases	Incidence of severe dengue cases reported to the surveillance system, by release zone and overall.	5 years
Secondary	Zika cases notified to surveillance system	Incidence of Zika cases reported to the surveillance system.	5 years
Secondary	Chikungunya cases notified to surveillance system	Incidence of chikungunya cases reported to the surveillance system.	5 years
Secondary	Spatial analysis	The spatial distribution of notified dengue cases with geolocated primary address available, before and after Wolbachia deployment	5 years
Secondary	Virologically-confirmed chikungunya infection	Virologically-confirmed chikungunya virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as chikungunya cases if plasma samples collected 1-4 days after onset of fever test positive for chikungunya virus NS1 antigen or chikungunya virus nucleic acid by RT-qPCR.	2 years
Secondary	Virologically-confirmed Zika infection	Virologically-confirmed Zika virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as Zika cases if plasma samples collected 1-4 days after onset of fever test positive for Zika virus NS1 antigen or Zika virus nucleic acid by RT-qPCR.	2 years

External Links

•   PECET Web Page