Antibiotic Resistance Prevention
Conditions
Brief summary
The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40/41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40/41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.
Interventions
DRUGAzithromycin
Antibiotic treatment (azithroymicin) for children with cryptosporidiosis is not currently recommended (supportive therapy only). The proposed modification to this study would involve randomly assigning the Cryptosporidium-positive children to two groups. Supportive treatment would be provided in both groups, but in one group, antibiotic treatment would be withheld. All children would continue to be monitored in accordance with standard protocols, and antibiotic treatment would be provided if deemed clinically necessary.
Sponsors
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
No
Inclusion criteria
* presenting with diarrheal symptoms * age under 1 year * enrolled in study NCT02764918
Exclusion criteria
* unwilling to give blood and stool samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T follicular helper activation | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibodies to pathogens | 1 year | Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41 |
| Reinfection | 1 year | Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41 |
| Measures of Malnutrition | 1 year | Weight, height |
Countries
Bangladesh
Contacts
CONTACTMary Young
Outcome results
None listed