Comparing a mosquito control intervention to standard community information to reduce the incidence of Buruli ulcer

A partially-blinded cluster randomized controlled, superiority trial to compare a multi-factorial mosquito control intervention to standard community information for the reduction of Buruli ulcer in the Mornington Peninsula, Victoria, Australia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88070918

Enrollment

8550

Registered

2019-01-11

Start date

2019-12-01

Completion date

Unknown

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Buruli ulcer Infections and Infestations Cutaneous mycobacterial infection

Interventions

The study area comprises 76 small area clusters lying within the Rosebud-Portsea region of the Mornington Peninsula, Victoria, Australia. Clusters are generated by randomly allocating combinations of

the number required to achieve sufficient statistical power (80%) to detect a significant difference in the primary outcome measure). Clusters are matched in pairs. Pairs are made based on clusters ha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Resident of a control or intervention area. 2. Visitor to a control or intervention area.

Exclusion criteria

Exclusion criteria: 1. Do not reside in control or intervention areas 2. Did not visit these areas and develop Buruli ulcer during the study period.

Design outcomes

Primary

Measure	Time frame
The incidence rate of Buruli ulcer in intervention areas compared with the incidence rate in control areas for the period 1 Dec 2019 - 31 Dec 2020. When calculating the incidence rate in intervention areas, the numerator is the count of notified Buruli ulcer cases whose residential addresses lie in an intervention cluster. The denominator is the estimated resident population of the intervention area, which is obtained from the Australian Bureau of Statistics. The incidence rate for control areas is calculated in the same way using corresponding data.	—

Measure

Time frame

The incidence rate of Buruli ulcer in intervention areas compared with the incidence rate in control areas for the period 1 Dec 2019 - 31 Dec 2020. When calculating the incidence rate in intervention areas, the numerator is the count of notified Buruli ulcer cases whose residential addresses lie in an intervention cluster. The denominator is the estimated resident population of the intervention area, which is obtained from the Australian Bureau of Statistics. The incidence rate for control areas is calculated in the same way using corresponding data.

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Secondary

Measure	Time frame
1. Count of trapped mosquitoes captured in intervention areas compared with the count of trapped mosquitoes captured in control areas using mosquito surveillance traps over the period 1 Dec 2019 – 30 Apr 2020. 2. Count of Buruli ulcer cases linked to intervention areas compared to the count of cases linked to control areas over the period 1 Dec 2019 – 31 Dec 2020. ‘Linked’ is defined as a case either having a residential address in the intervention/control area, or having visited one such area and stayed there for at least one night at the time symptoms of Buruli ulcer first appeared. This information is provided in the case notification data. 3. To quantify by PCR the concentration of M. ulcerans in different species of trapped mosquitoes at selected sites, both in control and intervention areas on the Mornington Peninsula, over the period 1 Dec 2019 – 30 Apr 2020. Mosquito species will be determined by entomologists.	—

Measure

Time frame

1. Count of trapped mosquitoes captured in intervention areas compared with the count of trapped mosquitoes captured in control areas using mosquito surveillance traps over the period 1 Dec 2019 – 30 Apr 2020. 2. Count of Buruli ulcer cases linked to intervention areas compared to the count of cases linked to control areas over the period 1 Dec 2019 – 31 Dec 2020. ‘Linked’ is defined as a case either having a residential address in the intervention/control area, or having visited one such area and stayed there for at least one night at the time symptoms of Buruli ulcer first appeared. This information is provided in the case notification data. 3. To quantify by PCR the concentration of M. ulcerans in different species of trapped mosquitoes at selected sites, both in control and intervention areas on the Mornington Peninsula, over the period 1 Dec 2019 – 30 Apr 2020. Mosquito species will be determined by entomologists.

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Countries

Australia

Contacts

Public ContactJane Oliver

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026