Removal of Chlamydia trachomatis from the face of children aged 1-7 years with ocular C. trachomatis infection Infections and Infestations
Conditions
Interventions
Participants are randomized to one of the three arms in a 1:1:1 ratio at the point of wash using a random number generator:
Protocol A: Caregiver delivers a 30-second face wash with water only
Protoco
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Parental consent to take part 2. Participant assent to take part 3. Severe conjunctival inflammation (F3 and/or P3) 4. Aged 1-7 years residents of Oromia State, Ethiopia 5. Availability for the study period (8 hours)
Exclusion criteria
Exclusion criteria: 1. Known allergy to study materials 2. Significant facial and/or ocular injury or pathology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative reduction in the proportion of participants without Chlamydia trachomatis detected on faces by real-time PCR immediately following face washing with soap and water, compared with the face washing with water only group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relative reduction in the proportion of participants without Chlamydia trachomatis detected on faces by real-time PCR immediately following face wiping with the SuperTowel, as compared to the water-only arm 2. Difference between arms in the proportion of participants without ocular or dry nasal discharge on faces, measured by consensus observation, immediately following washing/wiping protocol 3. Difference between arms in the mean load of Chlamydia trachomatis on faces, measured by real-time PCR, immediately following the washing/wiping protocol 4. Difference between arms in the proportion of participants without Chlamydia trachomatis (by real-time PCR)/ocular and nasal discharge (by consensus observation) on faces at 1, 2, 4, 6 and 8 hours following the washing/wiping protocol 5. Mean increase in load of Chlamydia trachomatis, measured by real-time PCR, on faces at 1, 2, 4, 6 and 8 hours following protocol | — |
Countries
Ethiopia
Outcome results
None listed