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Clinical Trials/CTRI/2025/02/081462
CTRI/2025/02/081462CompletedNot Applicable

Evaluating effectiveness of 300 mg of Posaconazole in Immunocompromised patients: an observational study.

Bajaj Healthcare Limited2 sites in 1 country25 target enrollmentStarted: March 3, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
2
Primary Endpoint
To determine the plasma concentrations of Posaconazole 300 mg using therapeutic
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This protocol aims to investigate the efficacy and safety of posaconazole 300 mg (Posatral 300mg) tablet across various clinical indications in immunocompromised patients. By conducting a TDM for posaconazole and evaluating the impact of routine laboratory measurements on posaconazole concentrations, we seek to provide insights that can enhance the routine clinical use of posaconazole and optimize patient care.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 55.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients prescribed posaconazole 300 mg tablet and are required to undergo TDM for fungal prophylaxis or treatment in various clinical settings.

Exclusion Criteria

  • •Patients with contraindications to posaconazole use.
  • •Patients with incomplete medical records that impede thorough analysis.
  • •Non-compliant patients who fail to adhere to the prescribed treatment regimen or timing.
  • •Patients prescribed posaconazole for off-label indications not approved by regulatory authorities.

Outcomes

Primary Outcomes

To determine the plasma concentrations of Posaconazole 300 mg using therapeutic

Time Frame: Day 1 and Day 7

drug monitoring

Time Frame: Day 1 and Day 7

Secondary Outcomes

  • To evaluate clinical outcomes, assess safety and adverse events, and analyze the correlation between TDM parameters and laboratory markers(Day 1 and Day 7)

Investigators

Sponsor
Bajaj Healthcare Limited
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Vijaykumar Patil

Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital

Study Sites (2)

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