Laoprasopwattana, K., Khwanna, T., Suwankeeree, P., Sujjanunt, T., Tunyapanit, W., & Chelae, S. (2013). Ciprofloxacin reduces occurrence of fever in children with acute leukemia who develop neutropenia during chemotherapy. Pediatric Infectious Disease Journal, 32(3), e94–e8.

The purpose of the study was to establish efficacy for the use of fluroquinolones in reducing the occurrence of fever in pediatric patients undergoing chemotherapy.

Patients were randomly assigned to receive 10 mg/kg per day of ciprofloxacine orally or placebo twice daily within five days after beginning chemotherapy. Young children who could not take pills were given a liquid form. Axillary temperatures were to be taken every eight hours. Outpatients were seen weekly for evaluation.

• 95 total patients
• Patients were aged 3 months to 18 years
• Patients had acute lymphoblactic leukemia and lymphoma

A single-site inpatient setting.

• The phase of care was active antitumor treatment
• The application was in pediatrics

The study was a prospective, double-blind, randomized, placebo-controlled trial.

• Bacterial isolation tests for infection sites and rectal swabs.
• Infections classified as microbiologically documented, clinically documented, or fever of unknown origin.

The median duration (IQR) of prophylaxis was longer in the ciprofloxacin group than in the placebo group (18 days [5–30] versus 10 days [3–15], p = 0.031). The number of patients who continued the intervention after discharge from the hospital also was higher in the ciprofloxacin group than in the placebo group (18/45 (40%) versus 10/50). In 71 patients with neutropenia, a lower proportion developed fever in the ciprofloxacin group than in the placebo group (17/34 [50%] versus 27/37 [73%]; absolute difference in risk, -23%; 95% CI [-45%, -0.9%]; p = 0.046). In subgroup analysis of patients with ALL, again the proportion of patients who developed fever was significantly lower in the ciprofloxacin group than in the placebo group (13/24 [54.2%] versus 24/30 [80%],  absolute difference in risk, -25.8%; 95% CI [-50.4%, -1.3%]; p = 0.042).

Ciprofloxacin can prevent fever in neutropenic patients with ALL during the induction phase of chemotherapy with good tolerance and no serious side effects.

The small sample (less than 100) was a limitation.

Ciprofloxacin was associated with lower incidence of fever in pediatric patients with neutropenia, and was not associated with significant side effects. There was no difference among patients who did not develop neutropenia. Patients with previous use of flouroquinolones as treatment may be  at risk of colonization with flouroquinolone-resistant bacteria, so empiric use in the setting of no neutropenia is not necessarily recommended.  Potential adverse effects of flouroquinolone use in children has been identified as a potential concern. This study provides some evidence in this area. Further research of appropriate prophylaxis in pediatric patients with cancer who are at high risk for infection is needed.