Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azithromycin.
- Who it may be relevant to
- Registry conditions: Antibiotic Resistance Prevention. Basic parameters: 6 months — 48 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 dee
Primary outcome measures
- T follicular helper activation [Time frame: 1 year]
Secondary outcome measures (3)
- Antibodies to pathogens [Time frame: 1 year]
- Reinfection [Time frame: 1 year]
- Measures of Malnutrition [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- presenting with diarrheal symptoms
- age under 1 year
- enrolled in study NCT02764918
Exclusion criteria
- unwilling to give blood and stool samples
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Bangladesh · 1 center
- Icddr,B — Dhaka
Publications
- Donowitz JR, Drew J, Taniuchi M, Platts-Mills JA, Alam M, Ferdous T, Shama T, Islam MO, Kabir M, Nayak U, Haque R, Petri WA. Diarrheal Pathogens Associated With Growth and Neurodevelopment. Clin Infect Dis. 2021 Aug 2;73(3):e683-e691. doi: 10.1093/cid/ciaa1938. PMID 33399861
- McCowin SE, Moreau GB, Haque R, Noble JA, McDevitt SL, Donowitz JR, Alam MM, Kirkpatrick BD, Petri WA, Marie C. HLA class I and II associations with common enteric pathogens in the first year of life. EBioMedicine. 2021 May;67:103346. doi: 10.1016/j.ebiom.2021.103346. Epub 2021 Apr 25. PMID 33910121
- Sullivan EF, Xie W, Conte S, Richards JE, Shama T, Haque R, Petri WA, Nelson CA. Neural correlates of inhibitory control and associations with cognitive outcomes in Bangladeshi children exposed to early adversities. Dev Sci. 2022 Sep;25(5):e13245. doi: 10.1111/desc.13245. Epub 2022 Feb 22. PMID 35192240
- Kabir M, Alam M, Nayak U, Arju T, Hossain B, Tarannum R, Khatun A, White JA, Ma JZ, Haque R, Petri WA Jr, Gilchrist CA. Nonsterile immunity to cryptosporidiosis in infants is associated with mucosal IgA against the sporozoite and protection from malnutrition. PLoS Pathog. 2021 Jun 28;17(6):e1009445. doi: 10.1371/journal.ppat.1009445. eCollection 2021 Jun. PMID 34181697
- Leslie JL, Weddle E, Yum LK, Lin Y, Jenior ML, Lee B, Ma JZ, Kirkpatrick BD, Nayak U, Platts-Mills JA, Agaisse HF, Haque R, Petri WA. Lewis Blood-group Antigens Are Associated With Altered Susceptibility to Shigellosis. Clin Infect Dis. 2021 Jun 1;72(11):e868-e871. doi: 10.1093/cid/ciaa1409. PMID 32940644
- Deichsel EL, Hillesland HK, Gilchrist CA, Naulikha JM, McGrath CJ, Van Voorhis WC, Rwigi D, Singa BO, Walson JL, Pavlinac PB. Prevalence and Correlates of Cryptosporidium Infections in Kenyan Children With Diarrhea and Their Primary Caregivers. Open Forum Infect Dis. 2020 Oct 31;7(12):ofaa533. doi: 10.1093/ofid/ofaa533. eCollection 2020 Dec. PMID 33335937
- Steiner KL, Kabir M, Hossain B, Gilchrist CA, Ma JZ, Ahmed T, Faruque ASG, Haque R, Petri WA. Delayed Time to Cryptosporidiosis in Bangladeshi Children is Associated with Greater Fecal IgA against Two Sporozoite-Expressed Antigens. Am J Trop Med Hyg. 2021 Jan;104(1):229-232. doi: 10.4269/ajtmh.20-0657. PMID 33078702
- Munday RM, Haque R, Wojcik GL, Korpe P, Nayak U, Kirkpatrick BD, Petri WA Jr, Duggal P. Genome-Wide Association Studies of Diarrhea Frequency and Duration in the First Year of Life in Bangladeshi Infants. J Infect Dis. 2023 Oct 18;228(8):979-989. doi: 10.1093/infdis/jiad068. PMID 36967705
Identifiers
NCT: NCT07615842 · 20388 · University of Virginia