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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-48
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

presenting with diarrheal symptoms

age under 1 year

enrolled in study NCT02764918

Disqualifiers

unwilling to give blood and stool samples

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin

    Drug

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Usual CareOther 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

T follicular helper activation

Time frame
1 year

Secondary outcomes

1

Antibodies to pathogens

Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41

Time frame
1 year
2

Reinfection

Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41

Time frame
1 year
3

Measures of Malnutrition

Weight, height

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

This trial is not recruiting at the moment. You can still explore other options: