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Imipenem/cilastatin versus Meropenem on Fever Defervescence in Septic Febrile Patient: A Comparative Prospective Study

Imipenem/cilastatin versus Meropenem on Fever Defervescence in Septic Febrile Patient: A Comparative Prospective Study

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Meropenem efficacy and tolerability was reported to measure up to
imipenem/cilastatin, though some data reported that it may be more efficient in
certain clinical and bacteriological settings. Our aim here is to demonstrate any
possible difference between the two carbapenems in major septic clinical scenarios.
Fever defervescence was selected as a clinical primary “broad” parameter to compare
the effectiveness of imipenem/cilastatin and meropenem on fever defervescence
in febrile septic patients.
Meropenem efficacy and tolerability was reported to measure up to
imipenem/cilastatin, though some data reported that it may be more efficient in
certain clinical and bacteriological settings. Our aim here is to demonstrate any
possible difference between the two carbapenems in major septic clinical scenarios.
Fever defervescence was selected as a clinical primary “broad” parameter to compare
the effectiveness of imipenem/cilastatin and meropenem on fever defervescence
in febrile septic patients.

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Published by: iMedPub on Jun 13, 2012
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iMedPub Journals
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© Under License o Creative Commons Attribution 3.0 License
1
2012
Vol.
2
No.
2:3
doi:
10.3823/712
THE INTERNATIONAL ARABIC JOURNALOF ANTIMICROBIAL AGENTS
Imipenem/cilastatinversus Meropenemon FeverDefervescencein Septic FebrilePatient: AComparativeProspective Study
1
Jordan Hospital and MedicalCenter.
2
The Specialty Hospital.
3
The Specialty Hospital.
4
Al Khalidi Medical Center.
5
Jordan Hospital.
Correspondence:
 
* Jordan Hospital and MedicalCenter, Amman, Jordan11844,
Jamal Ahmad Wadi M.D
1
* Fadi Shaqlose Pharm D
2
,Rawan Al Qasem Pharm D
3
, Rula Najjar Pharm D
4
,Wassim Abu Ashor Pharm D
5
Objective:
Meropenem efcacy and tolerability was reported to measure up toimipenem/cilastatin, though some data reported that it may be more efcient incertain clinical and bacteriological settings. Our aim here is to demonstrate anypossible dierence between the two carbapenems in major septic clinical scenarios.Fever deervescence was selected as a clinical primary “broad” parameter to com-pare the eectiveness o imipenem/cilastatin and meropenem on ever deerves-cence in ebrile septic patients.
Methods:
A prospective multicenter, observational, comparative open label study.The study was conducted in three hospitals between February – September 2009 inAmman-Jordan. Data were collected or patients whom were started on imipenem/ cilastatin or meropenem; the study team did not contribute to the antibacterialselection or patients.
Results:
Seventy patients were evaluated, thirty-two imipenem/cilastatin and thir-ty-eight meropenem treated patients. Age mean was 60 and 57.6 years or Imipe-nem/cilastatin and meropenem respectively. The APACHE II score was similar, mean14.4 or both study arms. There was no signifcant dierence in rates o clinicaldiagnoses or both study arms; ventilator-associated pneumonia (VAP), urinary tractinection (UTI), intra-abdominal inections (IAI), blood stream inection (BSI) or orothers sources. Additional anti-gram negative agents were administered in 10 and9 patients, added anti-MRSA agents in 11 and 12 patients, and antiungal agentsin 3 and 1 patient in imipenem/cilastatin and meropenem treated patients respec-tively. There was no signifcant dierence between the mean temperatures (38,6
0
C or both), antimicrobial utilization days (8.33 versus 6.67), mean days or everdeervescence (3.31 versus 2.37, p = 0.36, 95% C.I. (-1.09 - 2.98) or imipenem/ cilastatin and meropenem treated patients respectively, mortality was the same.
Conclusion:
There is no evidence to support the notion that there is clinical di-erence in ever deervescence between Imipenem/cilastatin and meropenem inthis evaluated group.
This article is available from:
www.iajaa.org
Introduction
Carbapenems are group o useul antibacterial agents thathave broad coverage including aerobic (Gram-positive andGram-negative) and anaerobic pathogens, they are reliableoption or the initial empiric treatment o serious inections(1, 2). Imipenem/cilastatin has been in the Middle East orover two decades, a relatively new carbapenem to the area,meropenem was lately introduced. Its efcacy and tolerability
 
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© Under License o Creative Commons Attribution 3.0 License
2012
Vol.
2
No.
2:3
doi:
10.3823/712
THE INTERNATIONAL ARABIC JOURNALOF ANTIMICROBIAL AGENTS
was reported to be similar to imipenem/cilastatin, thoughsome data reported that it may be more efcient in certainclinical and bacteriological studies. (1, 3) Our aim is to demon-strate any possible dierence between the two carbapenemsin major septic clinical scenarios. Fever deervescence wasselected as a clinical primary “broad” outcome measure andmortality as a secondary outcome measure to assess theircomparative efcacy. For the treating physician and patients,ever deervescence is a major parameter that demonstratesan adequate response in septic ebrile patients to the pre-scribed antibacterial.
Patients and methods
Study and setup
A prospective multicenter observational comparative openlabel study evaluating the dierence in ever deervescencein adult ebrile septic patients, when being treated with imi-penem/cilastatin or meropenem, the study was approved bythe internal review board o each hospital, study teams hasno inuence on the treating team or the selection o eitherantimicrobial. Patients’ selection took place by reviewing andollowing up cases which were treated with the concernedantibacterials. Sampling was done by recruiting all cases thatwere started on either carbapenem, the treating physiciansstart their patients on either carbapenem at their discretion.The administered doses were; imipenem/cilastatin 500 mgintravenous every 6 hours, or meropenem 1000 mg intrave-nous every 8 hours. The study took place in three hospitals inAmman-Jordan with 610 beds, with 69 ICCU beds. The threehospitals host an array o patients including cancer patients,bone marrow transplant, solid organ transplants includingkidney in all three hospitals, and one host in addition, livertransplants.
Diagnosis and recruitment of febrile septicpatient
All patients with ever were selected defned as; Single rectaltemperature o 38.2 C
0
measured within twenty-our hoursor two 38C
0
spikes o ever at least two hours apart, and sys-temic inammatory response syndrome (SIRS) with suspicionor documentation o microbial cause. (4) SIRS criteria (38°C <Temperature < 36°C, Heart rate > 90 beats/min, Respiratoryrate > 20 breaths/min, PaCO2 < 32 mm Hg, 12,000/mm3 <WBC < 4000/mm3, OR > 10% immature (band) orms). Pa-tients’ temperature was measured rectally. When (rarely) tem-perature was measured orally, a 0.5 C
0
was added as a cor-rection actor to account or rectal temperature. Normalizedtemperature is defned as any twenty-our hours without theabove defnition or ever. The acute physiologic and chronichealth evaluation (APACHE II) score is used as a measure opatient clinical illness severity.
Eligibility
Eligible patients are all ebrile septic patients who are ≥ 18years old. Both genders, meet defnition o ebrile sepsis,including patients with SSTI, CAP, HCAP, VAP (early and late),UTI, IAI, took carbapenem at least or three days, 500 mg i.v.every 6 hours or imipenem/cilastatin, or 1000 mg i.v. every8 hours or meropenem. Patients on previous antimicrobi-als with continuous ever judged to have no response e.g.anti-MRSA agent, and a study antimicrobial was added ornon-resolving ever.Excluded patient are <18 years old, pregnant women or lac-tating women, took the observed study antimicrobials orless than 3 days, ambiguity and repeated interruption otreatment and CNS inection. Blood culture growing MRSA,VRE or any organism resistant to either carbapenem, unlessthe patient was not improving on anti-MRSA agent and astudy antimicrobial was added or non-resolving ever. Pa-tients whom were on one study drug and switched to theother with ever deervescence in less than 48 hours. Pendingmortality defned as death or anticipated death within 24hours o patients being on either antimicrobial, in additionto violation o the defnition o septic patients.
Statistics
The aim o the study is to demonstrate whether there is adierence between imipenem/cilastatin and meropenem inhow many days it took either study antimicrobial to deer-vesce ever in treated patients. The comparison was done bytesting the proportion dierence between the deervescencedays o both antimicrobials. The assumption is that there wasno dierence, otherwise it would be rejected, and existenceo dierence is declared. Proportions’ dierence is assumednormality, its signifcance is tested by 95% confdence inter-val (C.I. 95%) and P ≤ 0.05 was accepted as signifcance level.The number o patients needed to be studied assuming nor-mal distribution ollowing z statistics is ≥ 30 per study arm.
Outcome measures
The primary measure is the days’ dierence in that imipenem/ cilastatin versus meropenem takes to normalize temperatureor ≥ 48 continuous hours. The secondary outcome measureis mortality by discharge, including mortality ater startingeither study antimicrobial.
 
THE INTERNATIONAL ARABIC JOURNALOF ANTIMICROBIAL AGENTS
© Under License o Creative Commons Attribution 3.0 License
2012
Vol.
2
No.
2:3
doi:
10.3823/712
3
iMedPub Journals
Our Site:
http://www.imedpub.com/
Results
Seventy patients were included, thirty-two in imipenem/cilas-tatin and thirty-eight in meropenem treated patients. Agemean was 60 years or Imipenem/cilastatin and 57.6 yearsor meropenem. The APACHE II scores were similar (mean= 14.4). The clinical diagnoses were almost similar betweenthe two groups or all diagnoses identifed like VAP (early andlate), UTI, IAI, BSI, undefned sepsis source or others diagnoses(
Table 1
). Additional gram-negative coverage in combinationwas utilized in 10 and 9 patients, added anti-MRSA agents in11 and 12 patients (though no MRSA was isolated later romboth arms) and antiungal agents in 3 and 1 respectively inimipenem/cilastatin and meropenem, without signifcant sta-tistical dierence (Data not shown). There was no signifcantstatistical dierence in morbidities or both arms includingdiabetes, hematological malignancies, solid tumors, chronicliver disease and cerebrovascular accidents, but there wereour cases o chronic renal ailure and one renal transplantin meropenem treated patients. There was no signifcant di-erence between the mean temperature (38,6
0
C or both)and antimicrobial utilization days (8.33 versus 6.67, dierence= 1.56, 95% P = 0.33, C.I -1.61 – 4.73). The outcome mea-sure; mean days or ever deervescence (3.31 versus 2.37,dierence = 0.94 days, p = 0.36, 95% C.I -1.09 - 2.98) orimipenem/cilastatin and meropenem respectively. Mortalityin both agents-treated patients was similar (
Table 2
).
Table 1.
Patients’ characteristics and demographic data orthe comparative study o imipenem/cilastatin &meropenem on ever deervescence in ebrile adultseptic Patient.
Characteristic
Imipenem/Cilastatin N= 32(%)MeropenemN = 38 (%)
Age in years60.0657.58
Gender Males21(65.6)28 (73.7)Females
11(34.4)10 (26.3)
APACHE II ScoreRangeMean ± S.D4 – 2714.43 ± 7.2622 -4014.45 ± 10.352≤ 10
1118
11 -20
129
≥ 21
711
Clinical Diagnosis
Early VAP 22Late VAP11UTI57IAI34BSI34CAP43HCAP11Sepsis (undefned)710Others*66
Morbidities
Diabetes mellitus1012
Chronic renalailure
04
Hematologicalmalignancy
21
Solid organtransplantrecipient
01
Solid tumor
42
Chronic liverdisease
11
Cerebrovascularaccidents
37
Others
1524
None
57
Not Available
73
Other Gram-Negative coverageAgents Added
109
Anti-MRSAAgents Added
1112
Anti-FungalAgents Added
31
Exclusion44
Others*: Hypertension, coronaryartery disease, and sot tissuerheumatism, MRSA: methicillin-resistant Staphylococcus aureusVAP: ventilator-associate pneumoniaIAI: intra-abdominal inectionCAP: community-acquiredpneumoniaHCAP: healthcare-associatedpneumoniaUTI: urinary tract inectionBSI: blood stream inection

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