This trial assessed the efficacy and safety of meropenem versus ceftazidime as empirical monotherapy for febrile neutropenia in paediatric cancer patients. In a prospective randomized study, 172 evaluable febrile episodes in the meropenem arm and 170 episodes in the ceftazidime arm were analysed for the clinical and microbiological response dependent on the kind of infection. About half the episodes were classified as fever of unknown origin (FUO) and the remainder as microbiologically or clinically documented infections. The most frequently documented infections in both arms were bacteraemias (22.1 versus 26.5%), predominantly caused by Gram-positive organisms (57.9 versus 71.1%). The success rate of the initial monotherapy differed significantly between the two arms and was 55.8% in the meropenem and 40.0% in the ceftazidime arm (P = 0.003). In addition, a significantly longer duration of fever and of antimicrobial therapy was observed in the ceftazidime arm than in the meropenem arm (median 5 versus 4 days, P = 0.022, and 7 versus 6 days, P = 0.009, respectively). With respect to the kind of infection, differences between the two arms were significant only in episodes classified as FUO but not in documented infections. In both arms, side effects were minimal. Despite the greater response rate for meropenem in FUO, the fact that ceftazidime has been proven to be as effective as meropenem in documented infections in the present study suggests that both drugs are useful as empirical monotherapy in febrile paediatric cancer patients.
ZusammenfassungOhne den sachkundigen Einsatz von Antibiotika kann das Ziel einer intensiveren Chemotherapie und letztlich eines verbesserten Langzeitüberlebens in der pädiatrischen Onkologie nicht erreicht werden. Während der Granulozytopenie und auch zwischen den intensiven Chemotherapien können bakterielle Infektionen die Lebensqualität des Patienten beeinträchtigen, das Leben des Patienten akut gefährden und den Ressourcenverbrauch im Rahmen der erforderlichen supportiven Behandlung massiv erhöhen. Der unkritische und nicht standardisierte Umgang mit Antibiotika kann den Patienten unnötigerweise mit Nebenwirkungen belasten und zur Selektion resistenter Bakterienspezies führen. Die vorliegende Arbeit enthält Empfehlungen der Arbeitsgruppe „Infektionen bei immunsupprimierten Kindern” der Deutschen Gesellschaft für Pädiatrische Infektiologie (DGPI) und der Deutschen Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) zur gezielten Therapie mit Antibiotika, insoweit sie für die Behandlung pädiatrisch-onkologischer Patienten von Interesse sind.
Bacterial infections are still a major challenge in the treatment of pediatric cancer patients. Considering the evidence in the literature and published consensus opinions of experts the following strategies of antibacterial chemoprophylaxis (ABCP) in pediatric cancer patients can be recommended (or not recommended): Accompanying the implantation of a ventriculoperitoneal shunt (or a Rickham-reservoir) ABCP is recommended, until prospective controlled studies including pediatric cancer patients have investigated this issue. In bone marrow or stem cell transplant recipients, the prophylactic administration of penicillin should be considered, if severe oral mucositis is a common adverse event in cancer departments with high rates of penicillin-susceptible strains of Streptococcus viridans. Prospective surveillance of resistant bacterial pathogens should be an indispensable tool of quality control in pediatric oncology departments. The risk of infection with antimicrobial-resistant isolates should be balanced against the real benefit of antimicrobial prophylaxis in every instance. ABCP should neither be given during implantation nor during prolonged usage to prevent bacterial infection of a central venous access device (unproven efficacy and potential hazards of Vancomycin-resistant gram-positive infections). The oral administration of non-absorbable ABCP or Trimetoprim-Sufomethoxazole is not recommended for the prevention of bacterial infections (unproven efficacy) and no recommendation can be given for the oral ABCP with chinolones (lacking data, risk of antimicrobial resistance).
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