A clinical trial to study the effects of Inj SUDOPEN (Doripenem 500 mg dry powder for injection), in patients with moderate to severe infections.

Safety, Tolerability and Efficacy of Inj SUDOPEN in the treatment of Moderate to Severe infections

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000248

Enrollment

100

Registered

2010-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: SUDOPEN inj (Doripenem 500 mg dry powder for injection): 500 mg IV infusion over 1hr thrice daily ( at every 8 hrs) Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, aged 18 years and above who give written informed consent 2. Subjects diagnosed with complicated UTI including pyelonephritis or nosocomial pneumonia or complicated intra-abdominal infections

Exclusion criteria

Exclusion criteria: 1. Subjects with known or suspected hypersensitivity to doripenem or carbapenem or other beta lactam antibiotics. 2. subjects in whom infection is judged to be severe or intractable that requires greater than 10 days of therapy or require additional antimicrobial agent (including intraperitoneal antibacterial agents) 3. Subjects with clinically significant cardiac, pulmonary,disorder other than nosocomial pneumonia, hepatic, renal (creatinine clearance? <30 ml/min), gastrointestinal disorders other than cIAI (such as pseudomembranous colitis, spontaneous bacterial peritonitis), hematologic or neurologic disease (including the subjects with seizure disorders receiving valproate). 4. Pregnant or breast-feeding women

Design outcomes

Primary

Measure	Time frame
Clinical cureTimepoint: At the end of study (day 7-10 post therapy)	—

Secondary

Measure	Time frame
Microbiological (eradication of pathogen)Timepoint: At the end of study (day 7-10 post therapy)	—

Countries

India

Contacts

Public ContactMonika Obrah

Anudeep.sandhu@ranbaxy.com+911244194395

Outcome results