BACKGROUND: The purpose of this randomized, controlled pilot study is to address the question whether normal hospital diet (NHD) is safe when compared with low-bacterial diet (LBD) given to prevent infections in cytopenic patients who receiveantimicrobial prophylaxis (AP). PATIENTS AND METHODS: The patients were randomized into two groups: one group to receive AP and LBD, the other to receive the same AP and NHD. The primary outcome parameter is colonization of the digestive tract with aerobic gram-negative bacilli and yeasts. Secondary outcome parameters were infections and total societal costs. RESULTS: No statistically significant differences between treatment groups were observed regarding the primary outcome parameter, gut colonization by yeasts or gram-negative bacilli, or infections, use of antimicrobials, days with fever and total societal costs. CONCLUSION: On the basis of the results of this pilot study, NHD appears to be as safe as LBD in patients with chemotherapy-induced cytopenia. Furthermore, the results indicate that LBD may offer no additional benefit as an infection preventive measure to the measures already implemented, such as AP. Thus, a larger randomized study, powered adequately to determine noninferiority of NHD to LBD is warranted and safe to be carried out.
RCT Entities:
BACKGROUND: The purpose of this randomized, controlled pilot study is to address the question whether normal hospital diet (NHD) is safe when compared with low-bacterial diet (LBD) given to prevent infections in cytopenic patients who receive antimicrobial prophylaxis (AP). PATIENTS AND METHODS: The patients were randomized into two groups: one group to receive AP and LBD, the other to receive the same AP and NHD. The primary outcome parameter is colonization of the digestive tract with aerobic gram-negative bacilli and yeasts. Secondary outcome parameters were infections and total societal costs. RESULTS: No statistically significant differences between treatment groups were observed regarding the primary outcome parameter, gut colonization by yeasts or gram-negative bacilli, or infections, use of antimicrobials, days with fever and total societal costs. CONCLUSION: On the basis of the results of this pilot study, NHD appears to be as safe as LBD in patients with chemotherapy-induced cytopenia. Furthermore, the results indicate that LBD may offer no additional benefit as an infection preventive measure to the measures already implemented, such as AP. Thus, a larger randomized study, powered adequately to determine noninferiority of NHD to LBD is warranted and safe to be carried out.
Authors: Elvira C van Dalen; Arno Mank; Edith Leclercq; Renée L Mulder; Michelle Davies; Marie José Kersten; Marianne D van de Wetering Journal: Cochrane Database Syst Rev Date: 2016-04-24
Authors: Sibylle C Mellinghoff; Jens Panse; Nael Alakel; Gerhard Behre; Dieter Buchheidt; Maximilian Christopeit; Justin Hasenkamp; Michael Kiehl; Michael Koldehoff; Stefan W Krause; Nicola Lehners; Marie von Lilienfeld-Toal; Annika Y Löhnert; Georg Maschmeyer; Daniel Teschner; Andrew J Ullmann; Olaf Penack; Markus Ruhnke; Karin Mayer; Helmut Ostermann; Hans-H Wolf; Oliver A Cornely Journal: Ann Hematol Date: 2017-12-07 Impact factor: 3.673