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Diarrhea InfectiousPhase 2TrtNDSDNCT07433426

The Impact of Shigellosis and Recommended Treatment in Children

A Phase 2 study testing Azithromycin in people with Diarrhea Infectious and Shigella, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children. Read more about this study

Who is it for?
Ages 6 to 59 months
What is being tested?
Azithromycin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
4 sitesin 2 countries
Study dates
18 Mar 2026to Aug 2030
Phase
Phase 2
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 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients >6 and ≤59 months of age seeking care in the study hospitals
  • Patients residing within the study catchment area
  • Present with watery diarrhea and positive for Shigella by RLDT
  • Willing to be available for sample and data collection during the follow up visits

Who cannot join

  • Inability or unwillingness of a participant's parent/guardian to give written informed consent or comply with study protocol
  • Diarrhea started more than 96 hours before enrollment
  • Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days
  • More than 2 doses of antidiarrheal drugs taken in the past 24 hours
  • History of allergy to Azithromycin
  • Presence of visible blood in stool
Show all 10Show fewer
  • Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).
  • History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment
  • Fever over 39°C (102°F) with other complications that require antibiotic treatment
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Subhra Chakraborty, PhD, MPH, MSc contact

410-502-3154

schakr11@jhu.edu

Melissa Higdon, MPH contact

mhigdon@jhu.edu

4 sites in 2 countries

Bangladesh2 sites, 2 recruiting

  • icddr,b Matlab Hospital

    Chāndpur

    Eva Sultana, MD, +8801641105930, eva.sultana1@icddrb.org

    Eva Sultana, MD

    Not yet recruiting

  • icddr,b Hospital

    Dhaka

    Sampa Dash, MD, +8801815858698, sampa.somc@gmail.com

    Sampa Dash, MD

    Recruiting

Other trials in Bangladesh

Zambia2 sites, 2 recruiting

  • Matero Level 1 Hospital

    Lusaka

    Chikumbutso Chipeta, M.D, MSc, +260969810681, chikumbutso.chipeta@cidrz.org

    chikumbutso Chipeta, MD

    Not yet recruiting

  • Arthur Davidson Children's Hospital

    Ndola

    Sam Miti, BSc HB,MBcHB,MMed,FZCOM-PEDS, +260966292508, drsammiti@gmail.com

    Mwizukanji Nachamba, MD, +260961950900, mwizukanjinachamba@gmail.com

    Not yet recruiting

Other trials in Zambia

About this study

The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.

Children with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits.

The investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.

Read the detailed description

The current World Health Organization (WHO) guidelines for the treatment of diarrhea recommend antibiotics when visible blood is present in the stool and in cases suspected of cholera. Currently, >50% of Shigella-associated diarrhea cases are non-dysentery or watery diarrhea in nature; thus, would not be treated with antibiotics according to guidelines. Absence of dysentery does not exclude Shigella as a cause of diarrhea and may not indicate a lower risk of death. For particularly vulnerable younger or malnourished children, identification and treatment of Shigella infection might be lifesaving. Consequently, a critical question remains to be answered. Should cases of non-dysentery Shigella associated watery diarrhea (NDSD) be treated with antibiotics? The goal of this study is to determine whether antibiotic treatment of NDSD cases improves clinical outcomes and growth in children.

This is a phase 2B, randomized, double-blind, placebo-controlled study. Children aged >6-59 months with NDSD who are seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive either Azithromycin or a placebo (a look-alike substance that contains no drug). All children will be rehydrated with either oral rehydration solution or intravenous fluids, depending on the degree of dehydration, and will receive zinc in accordance with standard of care. Enrolled children will be followed for three months through household visits to collect morbidity and anthropometry data.

Primary Outcomes

  • Time to Cessation of Diarrhea (TCD) between intervention and placebo
  • Change of Weight-for-age z-score (∆WAZ) in the 90 days following enrolment between intervention and placebo arms.

Secondary Outcomes

  • Change in linear growth measured as change in length-for-age z score (∆LAZ) in the 90 days following enrolment between the placebo and treatment arms
  • Time to microbiological cure between the intervention and placebo groups.
Being tested
Azithromycin, Placebo
Keywords
shigella, children, randomized clinical trial, weight for age, growth outcomes, Azithromycin, Diarrhea
Medical subject headings
Dysentery, Dysentery, Bacillary, Diarrhea

What participants receive

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

  • AzithromycinDrug

    Azithromycin will be given as 10 mg/kg body weight once daily for 5 days

  • PlaceboDrug

    Placebo will be similar in appearance to the intervention but will contain inactive ingredients.

Study groups in NCT07433426
Study groupRoleWhat they receive
AzithromycinExperimentalChildren 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days.
Receives: Drug: Azithromycin
PlaceboPlacebo comparatorChildren 6-59 months with non-dysentery Shigella diarrhea will receive placebo similar in appearance to the experimental drug once daily for 5 days.
Receives: Drug: Placebo

What is being measured

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

  1. Time to cessation of diarrhea (TCD)

    Diarrhea will be defined as 3 or more liquid or loose stool during a 24 hours period (not calendar day). Two diarrhea episodes will be separated by three diarrhea free days in between. Time to cessation of diarrhea (TCD) will be expressed in hours.

    Measured: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)

  2. Change in weight for age Z score (WAZ)

    The change in weight for age Z scores from enrollment to the 90-day follow-up

    Measured: From enrollment to the 90-day follow up

Secondary outcomes (2)

  1. Time to microbiological cure

    The interval between the administration of the intervention or placebo and two consecutive Shigella-negative stools by culture or Rapid LAMP-based Diagnostic test (RLDT) - a validated point-of-care diagnostic test.

    Measured: Enrollment to microbiological cure (up to 3 months)

  2. Change in length for age Z score (LAZ)

    Percentage change and mean difference in LAZ from enrollment to 90-day follow-up between the two arms.

    Measured: From enrollment to 90-day follow-up.

Timeline

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

  1. First posted25 Feb 2026
  2. Study start18 Mar 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2030 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07433426
Sponsor's protocol ID
IRB00033101
Other IDs
U01AI179562
Acronym
TrtNDSD
Status last verified
Mar 2026
First submitted
20 Feb 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dash S, Sultana E, Flynn K, Naz F, Ali M, Rahman MR, Rohman MM, Das S, Ahmed T, Faruque A, Chakraborty S. Evaluation of the performance and feasibility of RLDT in detecting Shigella in a primary healthcare facility of rural Bangladesh. medRxiv [Preprint]. 2025 Dec 11:2025.12.08.25341873. doi: 10.64898/2025.12.08.25341873.

    PubMed 41415506

  • Connor S, Velagic M, Zhang X, Johura FT, Chowdhury G, Mukhopadhyay AK, Dutta S, Alam M, Sack DA, Wierzba TF, Chakraborty S. Evaluation of a simple, rapid and field-adapted diagnostic assay for enterotoxigenic E. coli and Shigella. PLoS Negl Trop Dis. 2022 Feb 7;16(2):e0010192. doi: 10.1371/journal.pntd.0010192. eCollection 2022 Feb.

    PubMed 35130310

  • Chowdhury G, Ghosh D, Zhou Y, Deb AK, Mukhopadhyay AK, Dutta S, Chakraborty S. Field evaluation of a simple and rapid diagnostic test, RLDT to detect Shigella and enterotoxigenic E. coli in Indian children. Sci Rep. 2024 Apr 16;14(1):8816. doi: 10.1038/s41598-024-59181-6.

    PubMed 38627472

  • Chakraborty S, Connor S, Velagic M. Development of a simple, rapid, and sensitive diagnostic assay for enterotoxigenic E. coli and Shigella spp applicable to endemic countries. PLoS Negl Trop Dis. 2022 Jan 28;16(1):e0010180. doi: 10.1371/journal.pntd.0010180. eCollection 2022 Jan.

    PubMed 35089927

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azithromycin in people with Diarrhea Infectious and Shigella, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in 2 countries.

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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Bangladesh, Zambia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Subhra Chakraborty, PhD, MPH, MSc (410-502-3154, schakr11@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cessation of diarrhea (TCD) (time frame: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)). The study lists 2 primary outcomes in all. 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 NCT07433426, which also lists 4 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 30 Mar 2026.

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