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Impact of antifungal prophylaxis. A prospective, multicenter, observational study in India (MISFIC)

Incidence of invasive fungal infection in patients undergoing chemotherapy for acute myeloid leukemia â?? impact of antifungal prophylaxis. A prospective, multicenter, observational study in India (MISFIC) - MISFIC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/04/004544
Enrollment
200
Registered
2014-04-16
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- All patients with newly diagnosed /relapsed AML who undergo induction or salvage chemotherapy and receive antifungal prophylaxis will be included in the study.

Interventions

Intervention1: NOT APPLICABLE: NOT APPLICABLE Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

MSD PHARMA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients with newly diagnosed / relapsed AML (Both adult and pediatric patients); if they had or were anticipated to have neutropenia, with an absolute neutrophil count of 500 cells per cubic millimeter or less, for 7 days or more, resulting from remission-induction chemotherapy for newly diagnosed, or the first relapse of AML b) Willing to sign informed consent

Exclusion criteria

Exclusion criteria: a)Use of chemotherapy other than those mentioned. b)Invasive fungal infection within the previous 6 months, c)Clinically significant hepatic or renal dysfunction which precludes use of antifungal prophylaxis

Design outcomes

Primary

MeasureTime frame
The primary outcome studied would be the incidence of fungal infections in patients undergoing chemotherapy for AML.Timepoint: 4 WEEKS

Secondary

MeasureTime frame
Secondary outcomes would include the use of prophylaxis, mortality associated with fungal infections and adverse events associated with the use of antifungal drugs.Timepoint: 4 WEEKS

Countries

India

Contacts

Public ContactDr Biju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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