The Journal of pediatrics
-
The Journal of pediatrics · Jan 1983
Randomized Controlled Trial Comparative Study Clinical TrialOral antibiotic prophylaxis in patients with cancer: a double-blind randomized placebo-controlled trial.
In an attempt to reduce the incidence of fever and infection, we randomized patients with cancer to receive trimethoprim/sulfamethoxazole plus erythromycin (TMP/SMX + E) versus placebos after each cycle of chemotherapy (no crossover) and to continue until granulocytopenia (polymorphonuclear leukocytes less than 500/mm3) resolved or the patient became febrile. We evaluated 541 episodes (150 patients); 249 episodes (77 patients) with TMP/SMX + E and 292 episodes (73 patients) with placebos. The patients' median age was 17 years. ⋯ Patients with good or poor compliance showed no significant benefit from the TMP/SMX + E, and patients with excellent compliance did best, regardless of whether they were receiving antibiotics or placebos, suggesting that patient compliance is an important independent variable. The incidence of fever or infection was significantly lower for patients with leukemia with excellent compliance who received antibiotics (P = 0.037) than for patients with lymphomas or solid tumors. Oral antibiotic prophylaxis reduced the incidence of fever and infection in some granulocytopenic patients, but the benefit was limited and restricted to patients whose compliance was complete.