- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00142272
Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial
Randomised, Open, Parallel Group Clinical Trial to Compare the Efficacy and Safety of a Single Dose of Ciprofloxacin Oral Suspension 20 mg/kg With a 3-day Course of Erythromycin Oral Suspension Administered in a Dose of 12.5 mg/kg Every 6 Hours (12 Doses) in the Treatment of Children,With Clinically Severe Cholera Due to V. Cholerae O1 or O139.
The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139.
We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Dhaka, Bangladesh, 1212
- International Centre for Diarrhoeal Disease Research, Bangladesh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age: 2-15 years. Gender: male. Duration of illness: <24 hours. Written informed consent for participation in the study from either of the parents, or guardian, and oral assent from children aged ³ 8 years.
Severe dehydration according to World Health Organisation (WHO) guidelines. Positive stool dark field microscopic examination for V. cholerae.
Exclusion Criteria:
History of receiving any antimicrobial agent (including study drugs) effective in the treatment of V. cholerae within 72 hours of screening.
Concomitant infection(s) requiring antimicrobial therapy. A concomitant illness that may interfere with the evaluation of outcome or safety of the study drugs.
Patients with known chronic renal insufficiency. [As all cholera patients with moderate to severe dehydration have pre-renal insufficiency on admission, and as it is not possible to detect whether a patient has renal failure until the patient has been hydrated for at least 24 hours, serum creatinine will be checked 24 hours post-administration of first dose of study medication, on Day 5, and at any time as clinically indicated. (If the baseline creatinine is > 200 mcmol/L, any patient with creatinine > than 200 mcmol/L 24 hours post-administration, will be considered as suffering from renal failure and will be withdrawn from the trial.) Patients with known cardiac or hepatic impairment, i.e. SGOT/SGPT or bilirubin > 3 times the upper limit of normal, and patients with a history of central nervous system (CNS) disorders (known risk of experiencing seizures, a history of convulsive disorders or head injury trauma, currently on anti-seizure medication or within two months post-stroke).
Patients previously enrolled in the study. Patients participating in any clinical study within one month prior to study entry.
Patients' known to have AIDS. Patients treated with quinolones in the 14 days prior to the study. Patients known to have underlying rheumatological disease, joint problems, etc. Patients with a known hypersensitivity to any of the study drug regimens or related compounds (including fluoroquinolones and macrolides).
Female patients who are lactating, or are sexually active and using unreliable contraception.
Patients having a known underlying rheumatological disease, joint problems secondary to trauma or pre-existing conditions known to be associated with arthropathy.
Patients with conditions precluding the performance of a reliable series of musculoskeletal examinations are to be excluded from trial participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rates of clinical success
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Secondary Outcome Measures
Outcome Measure |
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Safety.
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Rates of bacteriologic success at test of cure visit.
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Duration of diarrhoea.
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Rates of clinical relapse.
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Rates of bacteriologic relapse.
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Duration of faecal excretion of V. cholerae O1 or V. cholerae O139.
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Measurements of six-hourly volume of watery stool will be done for the period in which patients are hospitalised.
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Proportion of patients requiring unscheduled intravenous fluids.
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Frequency of vomiting and its volume.
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Frequency of stool per day.
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Frequency of vomit per day.
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PK-assessment of serum and stool.
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Collaborators and Investigators
Investigators
- Study Director: Debasish Saha, MBBS,MS, International Centre for Diarrhoeal Disease Research, Bangladesh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vibrio Infections
- Cholera
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Ciprofloxacin
Other Study ID Numbers
- 2000-032_
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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