Fluconazole prophylaxis against fungal colonization and invasive fungal infection in very low birth weight infants.
BACKGROUND
Fungal infections are common cause of morbidity and mortality in very low birth weight Infants


OBJECTIVE
To evaluate the efficacy of prophylactic Fluconazole in preventing fungal colonization and invasive fungal infection in VLBW infants.


METHODS
Prospective, randomized, double blind placebo controlled clinical trial.


METHODS
Tertiary level Neonatal intensive care unit.


METHODS
120 preterm infants with birth Weight < 1500 g.


METHODS
Infants were randomly assigned during first three days to receive either Fluconazole or placebo till 28 days or less if, discharged or died earlier. Weekly surveillance cultures from groin, oropharynx, rectum and blood were collected in all patients. Fungal isolates were typed based on standard microbiologic techniques. Liver enzymes were monitored.


RESULTS
Baseline risk factors for fungal infection in Fluconazole and Placebo groups were similar. Fungal colonization was seen in 30 infants (50%) in the placebo group and 11 infants (19%) in the Fluconazole group (P <0.001). Fungal colonization at rectum, groin and oropharynx was less in fluconazole groups. Fluconazole group showed significantly lower colonizations with Candida albicans but not with C. glabrata. Invasive infection was seen in 15 (25%) infants in Placebo group and 16 (26.7%) infants in Fluconazole group (P = 0.835). Various non-albicans Candida were responsible for 96.8% cases of invasive fungal infection (Candida glabrata 71%, C. parapsilosis 14.7% and C. tropicalis 9.6%). No significant hepatotoxicity was noticed during Fluconazole therapy.


CONCLUSIONS
Prophylactic fluconazole during the first four weeks of life is effective in reducing fungal colonization but not invasive infection in VLBW infants.
Department of Neonatology, KEM Hospital and Seth GS Medical College, Mumbai 400 012, India. tbparikh@rediffmail.com
Tushar B
TB
Parikh
Ruchi N
RN
Nanavati
Chandrakant V
CV
Patankar
Suman
S
Rao
Kishore
K
Bisure
Rekha H
RH
Udani
Preeti
P
Mehta
D000935:Antifungal Agents / Q000627:therapeutic use*; D002177:Candidiasis / Q000517:prevention & control*; D004311:Double-Blind Method; D015725:Fluconazole / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight
D000935:Antifungal Agents; D015725:Fluconazole