Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial

NCT00142272 | Completed Phase 3

• 1 other identifier: 2000-032_
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholera

Keywords

Ciprofloxacin; children; V.cholerae O1 and O139; drug resistance; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Rates of clinical success

Secondary Outcomes (12)

• Rates of bacteriologic success at test of cure visit.

• Duration of diarrhoea.

• Rates of clinical relapse.

• Rates of bacteriologic relapse.

• Duration of faecal excretion of V. cholerae O1 or V. cholerae O139.

Interventions

Ciprofloxacin DRUG

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Bayer: collaborator
• NEMC: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Saha D, Khan WA, Karim MM, Chowdhury HR, Salam MA, Bennish ML. Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial. Lancet. 2005 Sep 24-30;366(9491):1085-93. doi: 10.1016/S0140-6736(05)67290-X.

  PMID: 16182896 DERIVED

MeSH Terms

Conditions

Cholera

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Debasish Saha, MBBS,MS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: May 1, 2001
• Study Completion: July 1, 2002
• Last Updated: February 11, 2022

Record last verified: 2005-09

Locations

BA (1)