NCT03429023

Brief Summary

This is an observational chart review of all patients with confirmed and probable diagnosis of mucormycosis at 19 centers across Indian hospital. Data will collect using a standardized CRF. All collected data will be entered into a database prior to analysis. Broadly data will be collected on demography, clinical characteristics, diagnosis, treatment and outcome for each patient. Patient will continue to receive treatment as per treating physicians advise. Primary outcome for this study will be overall survival at 45 \& 90 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

July 29, 2017

Last Update Submit

February 8, 2018

Conditions

Keywords

Mucormycosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Number of deaths

    Three months after the completion of the study

Eligibility Criteria

Age1 Day - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

13 hospitals are identified across India for this study. All patients diagnose with confirmed and probable mucormycosis

You may qualify if:

  • All consecutive patients regardless of age with a confirmed diagnosis mucormycosis through HPE \& /or culture will be enrolled in this study. In suspected cases on histopathology, molecular technique of extraction of DNA from tissue and sequencing to identify the pathogen, will be used to confirm the diagnosis
  • All probable cases of mucormycosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sterling Hospital

Ahmedabad, Gujarat, 380052, India

Location

St.Johns Medical College

Bangalore, Karnataka, 560034, India

Location

PD Hinduja National Hospital and Medical Research centre

Mumbai, Maharashtra, 400016, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Sir Gangaram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

VMMC and Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, India

Location

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

Sri Ramachandra Medical College & RI

Chennai, Tamil Nadu, 600116, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Nizams Institute Of Medical Sciences

Hyderabad, Telangana, 500082, India

Location

PGIMER

Chandigarh, India

Location

JIPMER

Puducherry, 605006, India

Location

MeSH Terms

Conditions

MycosesMucormycosis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsZygomycosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman FISF

Study Record Dates

First Submitted

July 29, 2017

First Posted

February 12, 2018

Study Start

April 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations