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A clinical trial which is for various bacterial infections

An open labeled, randomized, comparative study to evaluate the Efficacy and Safety of Etimicin Sulphate v/s Amikacin in patients suffering from various bacterial infections

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001046
Enrollment
200
Registered
2010-07-19
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

Health Condition 1: null- bacterial infections like Urinary Tract Infections , skin and Skin structure infections, Lower respiratory tract infection,Surgical infections

Interventions

Intervention1: Etimicin Sulphate: 4.5mg/kg/day for 5-10 days depending upon severity of infections Control Intervention1: Amikacin: 15 mg/kg/day divided into 2 or 3 equal doses The usual duration of

Sponsors

Venus Remedies Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects in the age group of above 18 years till 60 years shall be selected. Presence of an abnormal chest x-ray (CXR) as determined by the primary care team in case of LRTI patients Clinically diagnosed subjects with Respiratory tract infections mainly LRTI (Lower respiratory tract infections) , skin & skin structure infections, UTI (Urinary tract infections), surgical infections Patients or legal guardian or LAR (Legally acceptable representative) ready to give written informed consent.

Exclusion criteria

Exclusion criteria: History of hypersensitivity reaction or any specific contraindication to Aminoglycosides or Etimicin or Amikacin Presence of hepatic or renal disorders History of hearing loss Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
To evaluate the Efficacy of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections Timepoint: nil

Secondary

MeasureTime frame
To evaluate the Safety and tolerability of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections Timepoint: Nil

Countries

India

Contacts

Public ContactMr Pankaj
cra@venusremedies.com01795302024

Outcome results

None listed

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