Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Primary Purpose
Invasive Candidiases
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Fluconazole
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Invasive Candidiases
Eligibility Criteria
Inclusion Criteria: Preterm babies born less than 34 weeks of gestation very low birth weight babies (weighing < 1500 g at birth) Babies <72 hours of age Exclusion Criteria: Babies >72 hours of life Syndromic babies Babies with suspected metabolic disorders
Sites / Locations
- Services Hospital Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prophylactic Fluconazole
placebo group
Arm Description
12 mg/Kg loading dose of fluconazole given intravenously followed by 6 mg/Kg every 48 hours till 14 days of life, and then 6 mg/kg/day thereafter, for a total duration of 6 weeks (42 days).
Normal Saline 2cc given intravenously
Outcomes
Primary Outcome Measures
Invasive candidiases
Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.
Secondary Outcome Measures
Full Information
NCT ID
NCT05848492
First Posted
April 27, 2023
Last Updated
April 27, 2023
Sponsor
Services Institute of Medical Sciences, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT05848492
Brief Title
Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Official Title
Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing <1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic Fluconazole
Arm Type
Experimental
Arm Description
12 mg/Kg loading dose of fluconazole given intravenously followed by 6 mg/Kg every 48 hours till 14 days of life, and then 6 mg/kg/day thereafter, for a total duration of 6 weeks (42 days).
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Normal Saline 2cc given intravenously
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.
Primary Outcome Measure Information:
Title
Invasive candidiases
Description
Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Preterm babies born less than 34 weeks of gestation
very low birth weight babies (weighing < 1500 g at birth)
Babies <72 hours of age
Exclusion Criteria:
Babies >72 hours of life
Syndromic babies
Babies with suspected metabolic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Tauseef Omer, MBBS FCPS Pediatrics
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
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