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Prophylactic co-trimoxazole versus norfloxacin in neutropenic children — perspective randomized study

Vergleichende prospektive randomisierte Studie zur prophylaktischen Anwendung von Co-trimoxazol oder Norfloxacin bei neutropenischen Kindern

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Summary

Co-trimoxazole or norfloxacin were randomly administered to 44 granulocytopenic children with malignancies in order to prevent bacterial infections. Although more patients in the co-trimoxazole group had febrile episodes (p<0.01), the mean of febrile days and the mean of days with systemic antibiotics did not differ significantly in the two groups. Five patients in the co-trimoxazole group had a microbiologically documented infection (four with septicemia) due toEscherichia coli (n=2),Klebsiella pneumoniae, Pseudomonas aeruginosa, Streptococcus sp. There were four septicemic episodes in the norfloxacin group due toP. aeruginosa, Streptococcus pneumoniae, Streptococcus mitis andStreptococcus faecalis. Compliance was good during administration of both drugs. No signs or symptoms of arthropathy were seen in the norfloxacin group. The number of gram-negative bacilli resistant to co-trimoxazole isolated from stools significantly increased during prophylaxis with co-trimoxazole (p<0.001). Norfloxacin did not select resistant strains and was very active in eradicating gram-negative bacilli from stools (27.5% of positive cultures).

Zusammenfassung

44 Kinder, die an malignen Erkrankungen litten, erhielten zur Prävention bakterieller Infektionen während der granulozytopenischen Phase nach Randomverfahren entweder Co-trimoxazol oder Norfloxacin. Fieberzustände traten bei der mit Co-trimoxazol behandelten Gruppe häufiger auf (p<0,01), aber die Anzahl der Tage mit Fieber und die Anzahl der Tage, an denen eine systemische Antibiotikatherapie durchgeführt werden mußte, wiesen im Mittel keine signifikanten Unterschiede auf. Unter Co-trimoxazol-Prophylaxe traten fünf mikrobiologisch dokumentierte Infektionen auf (vier mit Septikämie); die Erreger warenEscherichia coli (n=2)Klebsiella pneumoniae, Pseudomonas aeruginosa undStreptococcus sp. In der Norfloxacin-Gruppe traten vier Septikämien auf, die durchP. aeruginosa, Streptococcus pneumoniae, Streptococcus mitis undStreptococcus faecalis verursacht wurden. Bei beiden Prophylaxeregimen war eine gute Compliance festzustellen. In der Norfloxacin-Gruppe waren keine Hinweise für eine Arthropathie zu finden. Unter Cotrimoxazol-Prophylaxe war eine signifikante Zunahme von gramnegativen Stuhlisolaten mit Resistenz gegen Co-trimoxazol festzustellen (p<0,001). Bei Norfloxacin war dagegen keine Selektion resistenter Stämme festzustellen, gramnegative Stäbchenbakterien wurden sehr effizient aus dem Stuhl eliminiert (27,5% der positiven Kulturen).

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Cruciani, M., Concia, E., Navarra, A. et al. Prophylactic co-trimoxazole versus norfloxacin in neutropenic children — perspective randomized study. Infection 17, 65–69 (1989). https://doi.org/10.1007/BF01646878

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