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SepsisNCT03344627

Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

A study testing Meropenem standard dose and Meropenem high dose in people with Sepsis and Septic Shock, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock, Critical Illness
What is being tested?
Meropenem standard dose and Meropenem high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteThailand
Study dates
27 Nov 2017to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis
  • Informed consent signed by patient or their legally authorized representative

Who cannot join

  • Subjects with infective endocarditis
  • Subjects with central nervous system infection
  • Subjects who requires surgical condition within 72 hours after randomization
  • Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization
  • Subjects with active seizure
  • History of receiving meropenem within 1 week prior to randomization
Show all 9Show fewer
  • Pregnancy women and lactation
  • Known allergy to meropenem
  • Not complete a 72-hour course of empirical meropenem treatment

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine Ramathibodi Hospital

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

Being tested
Meropenem standard dose, Meropenem high dose
Medical subject headings
Sepsis, Shock, Septic, Critical Illness, Multiple Organ Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meropenem standard doseDrug

    • Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours.
    • Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection.

  • Meropenem high doseDrug

    • Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours.
    • Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection
Study groups in NCT03344627
Study groupRoleWhat they receive
Meropenem standard doseActive comparatorMeropenem 1 g every 8 hours
Receives: Drug: Meropenem standard dose
Meropenem high doseActive comparatorMeropenem 2 g every 8 hours
Receives: Drug: Meropenem high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SOFA score change

    The Sequential organ failure assessment (SOFA) score describe the time course of multiple organ dysfunction.

    The SOFA score is composed of scores for six organ systems (respiratory, cardiovascular, neurological, hepatic, renal and coagulation).

    The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24.

    Primary outcome is assessing change between SOFA score at baseline and SOFA score at day 4 after treatment by meropenem

    Measured: Change from Baseline SOFA score at day 4

Secondary outcomes (8)

  1. Mortality

    In hospital mortality

    Measured: 14 and 28 days

  2. Clinical cure

    Composite of:

    1. Persistent fever and/or
    2. Stable or increased white blood cell count

    Measured: Day 3, 5, 7, 10 and 14

  3. Microbiological cure

    Elimination of the study entry pathogen within 14 days after received meropenem

    • Bacteremia: no growth in blood cultures
    • Intra-abdominal infection: no growth in blood cultures
    • UTI: uropathogen growth of less than 10^4 CFU/mL in women or less than 10^3 CFU/mL in men
    • HAP/VAP: pathogen in sputum culture growth of less than 10^3 CFU/mL
    • SSTI: no growth in blood cultures

    Measured: Day 3, 5, 7, 10 and 14

  4. Duration of vasopressor agents

    Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation

    Measured: 14 and 28 days

  5. Duration of mechanical ventilator

    Time interval (day) of mechanical ventilator

    Measured: 14 and 28 days

  6. Length of ICU stay

    Time interval (day) from ICU admission (after randomization) to ICU discharge

    Measured: 14 and 28 days

  7. Length of hospital stay

    Time interval (day) from hospital admission (after randomization) to hospital discharge

    Measured: 14 and 28 days

  8. %T > MIC

    % time of meropenem concentration above MIC

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start27 Nov 2017
  3. Primary completion30 Nov 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03344627
Sponsor's protocol ID
ID07-60-19
Status last verified
Mar 2019
First submitted
8 Nov 2017
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jaruratanasirikul S, Thengyai S, Wongpoowarak W, Wattanavijitkul T, Tangkitwanitjaroen K, Sukarnjanaset W, Jullangkoon M, Samaeng M. Population pharmacokinetics and Monte Carlo dosing simulations of meropenem during the early phase of severe sepsis and septic shock in critically ill patients in intensive care units. Antimicrob Agents Chemother. 2015;59(6):2995-3001. doi: 10.1128/AAC.04166-14. Epub 2015 Mar 9.

    PubMed 25753628

  • Roberts JA, Kumar A, Lipman J. Right Dose, Right Now: Customized Drug Dosing in the Critically Ill. Crit Care Med. 2017 Feb;45(2):331-336. doi: 10.1097/CCM.0000000000002210.

    PubMed 28098629

  • Suwantarat N, Carroll KC. Epidemiology and molecular characterization of multidrug-resistant Gram-negative bacteria in Southeast Asia. Antimicrob Resist Infect Control. 2016 May 4;5:15. doi: 10.1186/s13756-016-0115-6. eCollection 2016.

    PubMed 27148448

  • Blot SI, Pea F, Lipman J. The effect of pathophysiology on pharmacokinetics in the critically ill patient--concepts appraised by the example of antimicrobial agents. Adv Drug Deliv Rev. 2014 Nov 20;77:3-11. doi: 10.1016/j.addr.2014.07.006. Epub 2014 Jul 15.

    PubMed 25038549

  • Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.

    PubMed 25888181

  • Mouton JW, van den Anker JN. Meropenem clinical pharmacokinetics. Clin Pharmacokinet. 1995 Apr;28(4):275-86. doi: 10.2165/00003088-199528040-00002.

    PubMed 7648757

  • de Grooth HJ, Geenen IL, Girbes AR, Vincent JL, Parienti JJ, Oudemans-van Straaten HM. SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care. 2017 Feb 24;21(1):38. doi: 10.1186/s13054-017-1609-1.

    PubMed 28231816

  • Lertwattanachai T, Montakantikul P, Tangsujaritvijit V, Sanguanwit P, Sueajai J, Auparakkitanon S, Dilokpattanamongkol P. Clinical outcomes of empirical high-dose meropenem in critically ill patients with sepsis and septic shock: a randomized controlled trial. J Intensive Care. 2020 Apr 15;8:26. doi: 10.1186/s40560-020-00442-7. eCollection 2020.

    PubMed 32318268

Questions about this trial

What is this clinical trial studying?

A study testing Meropenem standard dose and Meropenem high dose in people with Sepsis and Septic Shock, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOFA score change (time frame: Change from Baseline SOFA score at day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03344627, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.

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