Last updated: June 5, 2023
Sponsor: Oxford University Clinical Research Unit, Vietnam
Overall Status: Completed
Phase
4
Condition
Gastroenteritis
Colic
Lactose Intolerance
Treatment
Ciprofloxacin
Azithromycin
Clinical Study ID
NCT03854929
26EN
Ages 6-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female aged 6 months to 60 months at time of hospital presentation.
- Have symptoms and/or signs of dysentery, specifically passing stools containing mucusand/or blood with/without abdominal pain, tenesmus or fever (≥37.8˚C).
- Be eligible for treatment with oral medication in the opinion of the admittingphysician (i.e. no clinical requirement for parenteral treatment on admission).
- Be within 72 hours of the onset of signs/symptoms.
- Have a parent/guardian present at admission who can provide written informed consent.
Exclusion
Exclusion Criteria:
- Those known to have specific medical (patients with known prolongation of the QTinterval, congenital long QT syndrome)/surgical conditions which may affect diseaseseverity/presentation or response to treatment (e.g. affecting antimicrobialabsorption), including:
- gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease.
- inherited or acquired immune system deficiency rendering the patientimmunocompromised, including chronic/long-term steroid treatment or otherimmunosuppressive treatment
- Presentation with severe infection requiring parenteral antimicrobial treatment,including shock jaundice, extensive gastrointestinal bleeding, convulsion , drowsinessor coma, reduced or less movement when stimulated, tachypnea > 60 times per minute,grunting, chest retraction, refuse to suck.
- Known hypersensitivity to any of the trial drugs (CIP or AZI).
- Coexisting infection requiring other or additional antimicrobials to be prescribed/administered.
Study Design
Total Participants: 364
Treatment Group(s): 2
Primary Treatment: Ciprofloxacin
Phase: 4
Study Start date:
December 11, 2019
Estimated Completion Date:
July 12, 2022
Study Description
Connect with a study center
Children's Hospital 2
Ho Chi Minh City, 70000
VietnamSite Not Available
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