A research study to compare 2 antibacterial drugs, gatifloxacin with ciprofloxacin, for the treatment of dysentery in children

A randomised controlled trial of gatifloxacin versus ciprofloxacin for the treatment of bacillary dysentery in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55945881

Enrollment

366

Registered

2008-01-18

Start date

2006-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shigella dysentery Digestive System Dysentery

Interventions

Patients are randomised to: 1. Ciprofloxacin 15 mg/kg body weight taken orally every 12 hours for a total of 6 doses in 3 days, or 2. Gatifloxacin 10 mg/kg body weight taken orally every 24 hours for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 0 - 14, either sex 2. Symptomatic uncomplicated dysentery 3. Gives consent

Exclusion criteria

Exclusion criteria: No consent given.

Design outcomes

Primary

Measure	Time frame
Failure of treatment: 1. Persistent fever at Day 5 2. Failure to clear completely the admission symptoms at Day 5 3. Stool culture positive at Day 3 of treatment 4. Need for ?rescue? treatment with ceftriaxone 5. The development on treatment of any complication	—

Secondary

Measure	Time frame
1. Fever clearance time: from the start of treatment until axillary temperature falls to 37.5°C and remains at or below this value for greater than 48 hours 2. Bloody diarrhoea clearance time: the time to the last stool containing visible blood passed 3. Diarrhoea clearance time: the time to the first formed stool 4. Bacterial clearance time: time to the last positive stools culture for Shigella	—

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026