AzTrials
AzTrials

Antibiotic Resistance PreventionPhase 1NCT07615842

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

A Phase 1 study testing Azithromycin in people with Antibiotic Resistance Prevention, run by University of Virginia at 1 site in Bangladesh.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 48 months
Conditions the study is for
Antibiotic Resistance Prevention
What is being tested?
Azithromycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteBangladesh
Study dates
1 Jun 2026to 1 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 48 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • presenting with diarrheal symptoms
  • age under 1 year
  • enrolled in study NCT02764918

Who cannot join

  • unwilling to give blood and stool samples

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mary Young contact

4348061737

mky4n@virginia.edu

Bangladesh1 site

  • Icddr,B

    Dhaka

    Rashidul Haque, 880-2-9862896, rhaque@icddrb.org

Other trials in Bangladesh

About this study

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.

Being tested
Azithromycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    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.

Study groups in NCT07615842
Study groupRoleWhat they receive
Usual CareOtherChildren 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.
Receives: Drug: Azithromycin
Standard of CareNo interventionChildren with cryptosporidium, rotavirus, and/or adenovirus 40/41 will not receive azithromycin, but will be treated by standard of care and supportive treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T follicular helper activation

    Measured: 1 year

Secondary outcomes (3)

  1. Antibodies to pathogens

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

    Measured: 1 year

  2. Reinfection

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

    Measured: 1 year

  3. Measures of Malnutrition

    Weight, height

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07615842
Sponsor's protocol ID
20388
Other IDs
University of Virginia
Status last verified
May 2026
First submitted
22 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Protected data will be deposited in dbGap at time of publication.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36967705

  • 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.

    PubMed 37333724

  • 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.

    PubMed 37347553

  • 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.

    PubMed 37425840

  • 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.

    PubMed 37832036

  • 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.

    PubMed 37568218

  • 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.

    PubMed 38524222

  • 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.

    PubMed 38536881

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azithromycin in people with Antibiotic Resistance Prevention, run by University of Virginia at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary Young (4348061737, mky4n@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T follicular helper activation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07615842, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in