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.
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
- Conditions the study is for
- Diarrhea Infectious, Shigella, Growth & Development
- 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
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- 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.
Melissa Higdon, MPH contact
4 sites in 2 countries
Bangladesh2 sites, 2 recruiting
- Not yet recruiting
icddr,b Matlab Hospital
Chāndpur
Eva Sultana, MD, +8801641105930, eva.sultana1@icddrb.org
Eva Sultana, MD
- Recruiting
icddr,b Hospital
Dhaka
Sampa Dash, MD, +8801815858698, sampa.somc@gmail.com
Sampa Dash, MD
Zambia2 sites, 2 recruiting
- Not yet 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
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.
- Conditions
- Diarrhea Infectious, Shigella, Growth & Development
- 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 group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Children 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days. Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Children 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.
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)
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)
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)
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.
- First posted25 Feb 2026
- Study start18 Mar 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diarrhea InfectiousStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subhra Chakraborty, PhD, MPH, MSc, Principal investigator, Johns Hopkins Bloomberg School of Public Health
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 41415506Connor 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 35130310Chowdhury 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 38627472Chakraborty 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Shigellosis and Recommended Treatment in Children
- ClinicalTrials.gov ID
- NCT07433426
- Acronym / sponsor ID
- TrtNDSD / IRB00033101
- Conditions
- Diarrhea Infectious, Shigella, Growth & Development
- Keywords
- shigella, children, randomized clinical trial, weight for age, growth outcomes, Azithromycin, Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: AzithromycinChildren 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboChildren 6-59 months with non-dysentery Shigella diarrhea will receive placebo similar in appearance to the experimental drug once daily for 5 days. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAzithromycin will be given as 10 mg/kg body weight once daily for 5 days | Drug | Azithromycin |
| PlaceboPlacebo will be similar in appearance to the intervention but will contain inactive ingredients. | Drug | Placebo |
Primary outcome
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)
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.
Change in weight for age Z score (WAZ)
Time frame: From enrollment to the 90-day follow up
The change in weight for age Z scores from enrollment to the 90-day follow-up
2 secondary outcomes
Time to microbiological cure
Time frame: Enrollment to microbiological cure (up to 3 months)
Change in length for age Z score (LAZ)
Time frame: From enrollment to 90-day follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 41415506Dash 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.
- Background: PubMed 35130310Connor 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.
- Background: PubMed 38627472Chowdhury 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.
- Background: PubMed 35089927Chakraborty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Higdon, MPH contact
Subhra Chakraborty, PhD, MPH, MSc principal investigator
Johns Hopkins Bloomberg School of Public Health
4 sites in 2 countries: see every site and its status.
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.