A clinical study to evaluate efficacy and safety of Metronidazole Injection manufactured by Nirma Limited for the treatment of Lower Respiratory Tract Infections, Intra abdominal infections and other bacterial infections.

An Open-Label clinical study to evaluate efficacy and safety of Metronidazole Injection manufactured by Nirma Limited for the treatment of Lower Respiratory Tract Infections, Intra abdominal infections and other bacterial infections.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/002988

Enrollment

Registered

2012-09-12

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- Lower Respiratory Tract Infections, Intra abdominal infections and other bacterial infections

Interventions

Intervention1: Metronidazole Injection 500 mg / 100 mL IV: Intervention (Test): Metronidazole Injection 500 mg / 100 mL IV administration over a period of 20 min. infusion at the rate of 5mL /min. Fre

Eligibility

Inclusion criteria

Inclusion criteria: • Patient within 18 â?? 65 years of age ( both inclusive) • Women of child bearing age with a normal menstrual cycle and a negative pregnancy test. • Patient suffering from Intra-Abdominal infection had to have signs/ symptoms such as abdominal pain, tenderness etc. A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteraemia in association with an intra-abdominal source of infection. • Patients suffering from lower respiratory tract infections ( LRTIs) had to have at least two of the following: fever ( > 98.6 Â° F) or hypothermia, cough with sputum, dyspnea, crackles, rales, pleuritic pain, dullness of percussion, and leukocytosis or leucopenia.

Exclusion criteria

Exclusion criteria: The patients will be excluded based on the following criteria : 1. History of previous allergy to Î²-lactam antibiotics or history of seizure. 2. History of consumption of any other antimicrobial agent within last 72 hours. 3. New drug trial in the three previous months. 4. History of severe cardiac, renal or haematological impairment. 5. Patients with continuing history of alcohol and / or drug abuse. 6. Increased hepatic or renal enzyme levels >3 times of the upper limit of the normal range. 7. Patient with terminal malignancy or psychiatric illness. 8. Pregnant or nursing woman.

Design outcomes

Primary

Measure	Time frame
1) Efficacy rate: The proportion of the â??cureâ?? and â??marked improvementâ?? categories will be employed to calculate the overall efficacy rate. Timepoint: None	—

Secondary

Measure	Time frame
2) Improvement in scores for signs and symptoms in patients of LRTIs, Intra abdominal infections or other bacterial infections with respect to baseline characteristics. 3) To evaluate safety of the study drug by incidence rates of adverse events. Timepoint: None	—

Countries

India

Contacts

Public ContactDr Chetan Patil

patilchetan@yahoo.com0253-2422480

Outcome results

None listed

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