Diarrhea Clinical Trial
— CIPAZOfficial title:
An Open Label Randomised Controlled Trial of Azithromycin Versus Ciprofloxacin for the Treatment of Children Hospitalised With Dysentery in Ho Chi Minh City, Vietnam
Verified date | June 2023 |
Source | Oxford University Clinical Research Unit, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City.
Status | Completed |
Enrollment | 364 |
Est. completion date | July 12, 2022 |
Est. primary completion date | February 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 60 Months |
Eligibility | Inclusion Criteria: 1. Male or female aged 6 months to 60 months at time of hospital presentation. 2. Have symptoms and/or signs of dysentery, specifically passing stools containing mucus and/or blood with/without abdominal pain, tenesmus or fever (=37.8°C). 3. Be eligible for treatment with oral medication in the opinion of the admitting physician (i.e. no clinical requirement for parenteral treatment on admission). 4. Be within 72 hours of the onset of signs/symptoms. 5. Have a parent/guardian present at admission who can provide written informed consent. Exclusion Criteria: 1. Those known to have specific medical (patients with known prolongation of the QT interval, congenital long QT syndrome)/surgical conditions which may affect disease severity/presentation or response to treatment (e.g. affecting antimicrobial absorption), including: 1. gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease. 2. inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment 2. Presentation with severe infection requiring parenteral antimicrobial treatment, including shock jaundice, extensive gastrointestinal bleeding, convulsion , drowsiness or coma, reduced or less movement when stimulated, tachypnea > 60 times per minute, grunting, chest retraction, refuse to suck. 3. Known hypersensitivity to any of the trial drugs (CIP or AZI). 4. Coexisting infection requiring other or additional antimicrobials to be prescribed/ administered. |
Country | Name | City | State |
---|---|---|---|
Vietnam | Children's Hospital 2 | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Oxford University Clinical Research Unit, Vietnam | Number 2 Children's Hospital, Ho Chi Minh City, University of Liverpool |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the Clinical treatment failure between treatment groups. | Clinical treatment failure including: fever =38.0°C or the persistence of signs or symptoms of the infection (vomiting, abdominal pain, passing loose stools more than 3 times per 24 hours ( with blood and mucus, blood or mucus, without both)) | after 120 hours of start of either treatment. | |
Primary | Assess the microbiological treatment failure between treatment groups. | The microbiological treatment failure is assessed by positive PCR stool with original pathogen after day 3 of treatment. | after 72 hours of start of either treatment. | |
Secondary | Measure differences in symptom duration between treatment groups by stratifying stool PCR. | Compare the duration of symptom ( from the onset to disappear) between the two groups.
The duration of symptom will be stratified by stool PCR. |
120 hours of start of either treatment. | |
Secondary | Measure differences in symptom duration between treatment groups by stratifying stool culture. | Compare the duration of symptom ( from the onset to disappear) between the two groups.
The duration of symptom will be stratified by stool culture. |
120 hours of start of either treatment. | |
Secondary | Assess the time to resolution of objective markers of infection and inflammation, including cessation of culture- and PCR-confirmed Shigella shedding, normalization of blood total white cell count, C-reactive protein and stool lipocalin | Time to cessation of Shigella shedding in stool (PCR). | at enrolment, day 7th (+3 days) and day 28th (+3 days) | |
Secondary | Assess the rates of adverse events associated with exposure to the antimicrobial agents used. | Adverse effects of antimicrobial treatment, including (i) life-threatening events, (ii) events requiring drug discontinuation, (iii) mild adverse events that require additional medication to be used but not resulting in drug discontinuation. | at enrolment, during 31 days after enrolment | |
Secondary | Assess the effects of antimicrobial exposure on the host microbiome, including diversity and abundance of specific bacterial species in stool. | The extend of intestinal microbial colonisation will be assessed by analyses of stool sample collected at enrolment, day 7th (+3 days) and day 28th (+3 days) | at enrolment, day 7th (+3 days) and day 28th (+3 days). |
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