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NOT YET RECRUITING
NCT07615842
PHASE1

Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

We are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. We 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 our 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. We will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.

Key Details

Gender

All

Age Range

6 Months - 48 Months

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06-01

Completion Date

2028-06-01

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Azithromycin

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.

Locations (1)

Icddr,B

Dhaka, Bangladesh