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Clinical Trials/CTRI/2012/04/002558
CTRI/2012/04/002558
Recruiting
Phase 4

A open label, observational, multicenter, prospective, post marketing surveillance study (PMS) to evaluate safety and efficacy of sulbactomax (FDC of Ceftriaxone + Sulbactam) in patients with various bacterial infections

Venus Remedies Limited0 sites2,500 target enrollmentTBD
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ConditionsHealth Condition 1: null- LRTI, UTI, BACTERIAL MENINGITIS, BACTERIAL SEPSIS, SKIN AND SOFT TISSUE INFECTION, GONORRHOEA, OTITIS MEDIA, SURGICAL PROPHYLAXIS, ENTERIC FEVER (TYPHOID FEVER), BONE AND JOINT INFECTIONS

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- LRTI, UTI, BACTERIAL MENINGITIS, BACTERIAL SEPSIS, SKIN AND SOFT TISSUE INFECTION, GONORRHOEA, OTITIS MEDIA, SURGICAL PROPHYLAXIS, ENTERIC FEVER (TYPHOID FEVER), BONE AND JOINT INFECTIONS
Sponsor
Venus Remedies Limited
Enrollment
2500
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria for LRTI:
  • •All age groups included (Pediatric, Adult and Geriatric)
  • •Subject is willing to participate as evidenced by signing the written informed
  • •consent form. LAR shall sign the ICF in case of illiterate subjects.
  • •New or increased respiratory signs or symptoms (i.e., cough, sputum
  • •production, dyspnea, auscultatory findings of abnormal breath sounds and
  • •rales, pleuritic chest pain) with or without inflammatory signs
  • •Presence of an abnormal chest x\-ray (CXR)
  • •Acute exacerbations of Chronic obstructive pulmonary disease (COPD) due
  • •to infection

Exclusion Criteria

  • •Exclusion criteria for LRTI:
  • •Any known hypersensitivity to active ingredients of SulbactomaxTM.
  • •Subject undergoing treatment with other active drug.
  • •Pulmonary embolism
  • •Active pulmonary tuberculosis
  • •Aspiration pneumonia
  • •Acute bronchial asthma without signs of lower respiratory tract infection
  • •Pulmonary oedema
  • •Subdiaphragmatic collection
  • •Cryptogenic Organising Pneumonitis (COP) and BOOP (Bronchiolitis

Outcomes

Primary Outcomes

Not specified

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