10-day antibiotic therapy noninferior to 14 days for GNB sepsis

Antibiotic therapy for 10 days is not inferior to 14 days therapy in nonvery low birth weight (non-VLBW) infants with Gram-negative bacterial (GNB) sepsis, a recent study has shown.

An open-label, noninferiority, randomized controlled trial was conducted on non-VLBW infants with GNB sepsis without meningitis whose blood culture were sterile after day 7 of treatment and who were in clinical remission on day 9 of appropriate antibiotic. Patients were randomly assigned to receive either short- (SDR; 10 days) or long-duration (LDR; 14 days) antibiotic therapy.

The authors sought primarily to compare treatment failure. In addition, they compared duration of hospitalization, complications of intravenous (IV) therapy and its duration, episodes of new-onset sepsis, and all-cause mortality.

Some 222 infants with GNB sepsis were identified, of whom 58 were randomized in each group; 113 were subsequently analysed. No difference was seen in the proportion of infants with multidrug-resistant organism in SDR versus LDR group (60 percent vs 55.1 percent; p=0.84). Treatment failure did not occur in either group.

Infants in the LDR group had longer duration of hospital stay (median, 20 vs 16 days; p<0.001) and required IV therapy for a longer period than those in the SDR group (mean, 15.2 vs 10.9 days; p<0.001). Moreover, the LDR group had higher episodes of extravasation (median, 5 vs 3; p<0.001).

No between-group difference was observed in episodes of phlebitis and haematoma. Fortunately, none of the infants died during follow-up.