To study the effect of a new drug in treatment of complicated urinary tract infections.

Effect of ceftriaxone sulbactam disodium EDTA combination in treatment of complicated urinary tract infection caused by metallo beta-lactamase producing gram negative bacilli an open label randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047325

Enrollment

Registered

2022-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: injection Ceftriaxone/sulbactam/disodium-edta: route- intravenous infusion over 90 minutes dose-3 grams in 100 ml normal saline frequency- twice a day duration- 5 to 14 days based on c

Eligibility

Inclusion criteria

Inclusion criteria: COMPLICATED UTI URINE CULTURE GROWING MBL PRODUCING GNB

Exclusion criteria

Exclusion criteria: MORIBUND PATIENTS MIXED GROWTH IN CULTURE ALLERGY TO MEDICATIONS

Design outcomes

Primary

Measure	Time frame
CLINICAL AND MICROBIOLOGICAL CLEARANCE OF BACTERIA FROM URINE.Timepoint: AFTER 14 DAYS OF TREATMENT	—

Secondary

Measure	Time frame
TO SEE RELAPSE OF BACTERIAL INFECTIONS IN COMPLICATED URINARY TRACT INFECTION CASESTimepoint: WITHIN 28 DAYS OF TREATMENT	—

Countries

India

Contacts

Public ContactSubhashree Samantaray

aiims jodhpur

mkgargs@gmail.com9438478537

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026