Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants
29. maj 2026 opdateret af: William Petri, MD, PhD, University of Virginia
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
150
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mary Young
- Telefonnummer: 4348061737
- E-mail: mky4n@virginia.edu
Studiesteder
-
-
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Dhaka, Bangladesh
- Icddr,B
-
Kontakt:
- Rashidul Haque
- Telefonnummer: 880-2-9862896
- E-mail: rhaque@icddrb.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- presenting with diarrheal symptoms
- age under 1 year
- enrolled in study NCT02764918
Exclusion Criteria:
- unwilling to give blood and stool samples
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Usual Care
Children with cryptosporidium, rotavirus and/or adenoviruses 40/41 will receive usual care provided by icddr,b, which includes standard of care, supportive treatment and azithromycin.
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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.
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Ingen indgriben: Standard of Care
Children with cryptosporidium, rotavirus, and/or adenovirus 40/41 will not receive azithromycin, but will be treated by standard of care and supportive treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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T follicular helper activation
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antibodies to pathogens
Tidsramme: 1 year
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Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41
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1 year
|
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Reinfection
Tidsramme: 1 year
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Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41
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1 year
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Measures of Malnutrition
Tidsramme: 1 year
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Weight, height
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Gilchrist CA, Campo JJ, Pablo JV, Ma JZ, Teng A, Oberai A, Shandling AD, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr. Specific Cryptosporidium antigens associate with reinfection immunity and protection from cryptosporidiosis. J Clin Invest. 2023 Aug 15;133(16):e166814. doi: 10.1172/JCI166814.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Williams FB, Kader MA, Dickson DM, Colgate ER, Alam M, Haque R, Petri WA Jr, Kirkpatrick BD, Lee B. Maternal Breast Milk Secretor Phenotype Does Not Affect Infant Susceptibility to Rotavirus Diarrhea. Open Forum Infect Dis. 2023 Jun 7;10(6):ofad299. doi: 10.1093/ofid/ofad299. eCollection 2023 Jun.
- Butler-Laporte G, Auckland K, Noor Z, Kabir M, Alam M, Carstensen T, Wojcik GL, Chong AY, Pomilla C, Noble JA, McDevitt SL, Smits G, Wareing S, van der Klis FR, Jeffery K, Kirkpatrick BD, Sirima S, Madhi S, Elliott A, Richards JB, Hill AV, Duggal P; PROVIDE authors, Cryptosporidiosis Birth Cohort authors; Sandhu MS, Haque R, Petri WA Jr, Mentzer AJ. Targeting hepatitis B vaccine escape using immunogenetics in Bangladeshi infants. medRxiv [Preprint]. 2023 Jun 29:2023.06.26.23291885. doi: 10.1101/2023.06.26.23291885.
- Carey M, Arju T, Cotton JA, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr, Gilchrist CA. Genomic Heterogeneity of Cryptosporidium parvum Isolates From Children in Bangladesh: Implications for Parasite Biology and Human Infection. J Infect Dis. 2023 Nov 2;228(9):1292-1298. doi: 10.1093/infdis/jiad257.
- Kupkova K, Shetty SJ, Pray-Grant MG, Grant PA, Haque R, Petri WA Jr, Auble DT. Globally elevated levels of histone H3 lysine 9 trimethylation in early infancy are associated with poor growth trajectory in Bangladeshi children. Clin Epigenetics. 2023 Aug 11;15(1):129. doi: 10.1186/s13148-023-01548-z.
- Chen L, Munday RM, Haque R, Duchen D, Nayak U, Korpe P, Mentzer AJ, Kirkpatrick BD, Wojcik GL, Petri WA Jr, Duggal P. Genetic Susceptibility to Astrovirus Diarrhea in Bangladeshi Infants. Open Forum Infect Dis. 2024 Mar 6;11(3):ofae045. doi: 10.1093/ofid/ofae045. eCollection 2024 Mar.
- Fahim SM, Donowitz JR, Smirnova E, Jan NJ, Das S, Mahfuz M, Gaffar SMA, Petri WA Jr, Marie C, Ahmed T. Small Intestine Bacterial Overgrowth is associated with increased Campylobacter and epithelial injury in duodenal biopsies of Bangladeshi children. PLoS Negl Trop Dis. 2024 Mar 27;18(3):e0012023. doi: 10.1371/journal.pntd.0012023. eCollection 2024 Mar.
- Campo JJ, Seppo AE, Randall AZ, Pablo J, Hung C, Teng A, Shandling AD, Truong J, Oberai A, Miller J, Iqbal NT, Penataro Yori P, Kukkonen AK, Kuitunen M, Guterman LB, Morris SK, Pell LG, Al Mahmud A, Ramakrishan G, Heinz E, Kirkpatrick BD, Faruque AS, Haque R, Looney RJ, Kosek MN, Savilahti E, Omer SB, Roth DE, Petri WA Jr, Jarvinen KM. Human milk antibodies to global pathogens reveal geographic and interindividual variations in IgA and IgG. J Clin Invest. 2024 Jun 11;134(15):e168789. doi: 10.1172/JCI168789.
- Surani Z, Turesky TK, Sullivan E, Shama T, Haque R, Islam N, Hafiz Kakon S, Yu X, Petri WA, Nelson C 3rd, Gaab N. Examining the relationship between psychosocial adversity and inhibitory control: A functional magnetic resonance imaging study of children growing up in extreme poverty. J Exp Child Psychol. 2025 Jan;249:106072. doi: 10.1016/j.jecp.2024.106072. Epub 2024 Sep 23.
- Van Fossen DM, Cho H, Wagar LE, Ma JZ, Parsonnet J, Haque R, Davis MM, Petri WA. Influence of environmental exposures on T follicular helper cell function and implications on immunity: a comparison of Bangladeshi and American children. mBio. 2025 Apr 9;16(4):e0398024. doi: 10.1128/mbio.03980-24. Epub 2025 Mar 10.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. juni 2028
Datoer for studieregistrering
Først indsendt
22. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20388
- University of Virginia (Andet bevillings-/finansieringsnummer: University of Virginia)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Protected data will be deposited in dbGap at time of publication.
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