NCT05540886

CLEAN Frontline: A Stepped Wedge Cluster Trial

Completed NA Last updated 29 October 2024

What this trial tests

NA trial testing TEACH CLEAN in Hospital Infections in 390 participants. Completed in 31 March 2023.

Timeline

1 March 2022

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	prevention
Enrollment	390
Start date	1 March 2022
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across Cambodia

Drugs / interventions tested

• TEACH CLEAN

Conditions studied

• Hospital Infections — all drugs for Hospital Infections →
• Environment, Controlled — all drugs for Environment, Controlled →
• Infection Control — all drugs for Infection Control →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Eligibility, any sex, with Hospital Infections or Environment, Controlled. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising.

The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals.

The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (\<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness.

Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of a multicomponent training intervention (Clean FrontLine) on microbiological cleanliness in Cambodian referral hospitals: a multicentre, stepped-wedge, cluster-randomised trial.
   Gon G, Ma S, Aiken AM, Dancer SJ, et al · · 2026 · PMID 41389803 · DOI 10.1016/j.lanmic.2025.101262