Health Condition 1: - Health Condition 2: null- Bacterial Infections: Respiratory tract infections, Urinary tract infections , gynaecological Infections and Bacterial meningitis
Conditions
Interventions
Intervention1: group 1 Meropenem 1000mg/ml injection for 04 days: group 1 Intervention (Meropenem 1000mg/ml) injection, 500 mg IV every 8 hours in the treatment of pneumonia, UTI and gynaecological in
Sponsors
BKRS PHARMA PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Male and female above 18 years with respiratory tract infection,urinary tract infection ,gynaecological infections, bacterial Meningitis ( any one of the disease). Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP Within 48 hours before starting empiric therapy a subject chest radiograph should show the presence of a New or progressive infiltrate, cavitation, or effusion suggestive of pneumonia Patients with VABP should have a clinical pulmonary infection score greater than or equal to 5 Lower Urinary tract infection symptoms(dysuria, urgency, frequency, suprapubic pain)
Exclusion criteria
Exclusion criteria: Metastatic hepatic disease Malignant ascites CNS disease, including metastatic CNS disease Cirrhosis, Adult respiratory distress syndrome Marked hepatic disease (bilirubin level, more than twice the upper limit of normal [ULN] or alanine aminotransferase level, more than four times the ULN) Known or suspected significant renal impairment (serum creatinine level, greater than 1.5 mg/dL) Neurosurgery within 1 month of entry into the trial Conditions treated with anticonvulsant medications Active colitis Exposure to other investigational drugs within days of trial entry Neutropenia History of Cystic fibrosis, polycystic Kidney Disease, cervical cancer, Poly microbial bacteremia. Auto-immune disease, lymphoma or leukemia Subjects with pneumonia caused by pathogens resistant to Meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure. In case of renal abscess, lack of early drainage Haematogenous infection or other concomitant infection Renal transplant recipients Partial or complete cervical excision Auto-immune disease Bacterial Vaginosis or Candidiasis (current or past 3 months) History of allergies to Beta-lactam antimicrobials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Clinical Evaluation of bacterial infectionsTimepoint: screening to End of Treatment ( Day-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the microbial response levels Incidence and rate of adverse events Timepoint: Screening to End of Treatment ( Day 4) | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed