Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

Invasive Candidiases Clinical Trial

Official title:

Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848492
• Other study ID #: FluconazolePreterm1
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2023
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Hour to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiases
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Fluconazole
Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.
• Saline
0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.

Locations

Country	Name	City	State
Pakistan	Services Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive candidiases	Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.	2 weeks