An Investigator initiated study comparing of two antifungals Anidulafungin and Caspofungin in patients with Invasive Candida Infections

Recruiting

• Conditions: Candidal sepsis,

• Registration Number: CTRI/2021/09/037013
• Lead Sponsor: Dr Yatin Mehta

Brief Summary

This is a prospective, observational,multicenter, open label study to evaluate and compare the safety and efficacyof 180 adult patients with Invasive Candida infection at 5-7 sites acrossIndia. Prior to being enrolled into the study patients must provide a writtenauthorization to the investigator to use or disclose personal and/or clinicaldata and meet the study eligibility criteria.

The data points to beconsidered in the study shall include demography, anthropometry, vital signs,body temperature, medical history, prior medications, risk factors for candida,candida scores, microbiology testing, laboratory assessments, concomitantmedication, clinical evaluation including APACHE II scores and microbiologicalevaluation, any treatment emergent adverse events, treatment given and anychange in dose or treatment during the hospitalization period

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Last Update Posted: 2023-10-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients of either sex with age ≥18 years with a confirmed cases of Invasive Candida infection.
• Patients who will be able to provide the informed consent.
• Patients prescribed with Caspofungin or Anidulafungin.

Exclusion Criteria

• Patients of either sex with age less than 18 years.
• Patients with aspergillus or any other mold or yeast [Cryptococcus] infections.
• Patients on Micafungin or other antifungal agents.
• Pregnant or breast-feeding women.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the efficacy and safety of Anidulafungin and Caspofungin in Invasive Candida infections in ICUs.	Day 1 to Day 14

Secondary Outcome Measures

Name	Time	Method
To determine the distribution pattern of co-morbidities and risk factors for Invasive Candida infection	Day 1 to Day 14
To determine the duration of treatment, number of hospital days and mortality of patients with Invasive Candida Infection.	Day 1 to Day 14
To assess the clinical signs and symptoms, baseline candida pathogen, candida scores	Day 1 to Day 14
To assess liver and renal functioning.	Day 1 to Day 14

Trial Locations

Locations (5)

Apollo Health City; 🇮🇳 Hyderabad, TELANGANA, India

Aster Medicity; 🇮🇳 Ernakulam, KERALA, India

Dayanand Medical College Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Medanta Institute of Critical Care and Anesthesiology; 🇮🇳 Gurgaon, HARYANA, India

Apollo Health City

🇮🇳Hyderabad, TELANGANA, India

Dr Vishnu Rao

Principal investigator

9966769630

vishpolati@gmail.com