CAMERA : Combination of Vancomycin and β-Lactam Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: A Pilot Multicenter Randomized Controlled Trial.

CAMERA study

Combination of Vancomycin and β-Lactam Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: A Pilot Multicenter Randomized Controlled Trial.

オーストラリア7施設によるMRSA菌血症に対する併用療法パイロットRCT

新薬開発が滞っているので、重要性が高い研究。

P : MRSA bacteremia

E :  vancomycin 1.5 g intravenously twice daily + intravenous flucloxacillin 2 g every 6 hours for 7 days (combination group) n=31

C : vancomycin 1.5 g intravenously twice daily (standard therapy group) n=29

O : 

• The mean duration of bacteremia : 3.00 days(combination group) vs 1.94 days (combination group).
• According to a negative binomial model, the mean time to resolution of bacteremia in the combination group was 65% (95% confidence interval, 41%-102%; P = .06) that in the standard therapy group.
• There was no difference in the secondary end points of 28- and 90-day mortality, metastatic infection, nephrotoxicity, or hepatotoxicity.

T : open-label, multicenter, RCT,  7 Australian hospitals

サンプルサイズ計算はNEJMの論文から計算

www.ncbi.nlm.nih.gov

A sample size of 60 was calculated to determine the duration of bacteremia in each group with a 95% confidence interval (CI) of ±2 days, assuming that the duration of bacteremia has a normal distribution with a standard deviation (SD) of 5.1 days  and a 10% correction factor for dropouts.

感想

 死亡率からサンプルサイズ計算していないが、差がないことから併用の必要性があるかどうかは、判断難しい。また、腎毒性も注意が必要だろう。

CAMERA2に期待。

www.ncbi.nlm.nih.gov

なお、著者のDavis JSさんは、sepsisに対して、抗菌薬持続点滴RCTをCDIに報告している。

https://www.ncbi.nlm.nih.gov/pubmed/?term=Davis%20JS%5BAuthor%5D&cauthor=true&cauthor_uid=26349552