BACKGROUND: Fungal infections are common cause of morbidity and mortality in very low birth weight Infants OBJECTIVES: To evaluate the efficacy of prophylactic Fluconazole in preventing fungal colonization and invasive fungal infection in VLBW infants. DESIGN: Prospective, randomized, double blind placebo controlled clinical trial. SETTING:Tertiary level Neonatal intensive care unit. SUBJECTS:120 preterm infants with birth Weight <; 1500 g. INTERVENTION: 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. CONCLUSION:Prophylactic fluconazole during the first four weeks of life is effective in reducing fungal colonization but not invasive infection in VLBW infants.
RCT Entities:
BACKGROUND:Fungal infections are common cause of morbidity and mortality in very low birth weight Infants OBJECTIVES: To evaluate the efficacy of prophylactic Fluconazole in preventing fungal colonization and invasive fungal infection in VLBW infants. DESIGN: Prospective, randomized, double blind placebo controlled clinical trial. SETTING: Tertiary level Neonatal intensive care unit. SUBJECTS: 120 preterm infants with birth Weight < 1500 g. INTERVENTION: 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. CONCLUSION: Prophylactic fluconazole during the first four weeks of life is effective in reducing fungal colonization but not invasive infection in VLBW infants.
Authors: Daniel K Benjamin; Barbara J Stoll; Marie G Gantz; Michele C Walsh; Pablo J Sánchez; Abhik Das; Seetha Shankaran; Rosemary D Higgins; Kathy J Auten; Nancy A Miller; Thomas J Walsh; Abbot R Laptook; Waldemar A Carlo; Kathleen A Kennedy; Neil N Finer; Shahnaz Duara; Kurt Schibler; Rachel L Chapman; Krisa P Van Meurs; Ivan D Frantz; Dale L Phelps; Brenda B Poindexter; Edward F Bell; T Michael O'Shea; Kristi L Watterberg; Ronald N Goldberg Journal: Pediatrics Date: 2010-09-27 Impact factor: 7.124
Authors: Kevin Watt; Paolo Manzoni; Michael Cohen-Wolkowiez; Stefano Rizzollo; Elena Boano; Evelyne Jacqz-Aigrain; Daniel K Benjamin Journal: Curr Drug Metab Date: 2013-02 Impact factor: 3.731