BridgeMD
New treatment option for Diarrhea Infectious
Official title The Impact of Shigellosis and Recommended Treatment in Children
ClinicalTrials.gov ID: NCT07433426
What this study is testing
What is Azithromycin?
Azithromycin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diarrhea infectious.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chāndpur, Bangladesh
- Dhaka, Bangladesh
- Lusaka, Zambia
- Ndola, Zambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chāndpur, Bangladesh; Dhaka, Bangladesh; Lusaka, Zambia; Ndola, Zambia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.