TraumaPhase 3MUSEUMNCT03159078
Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens
A Phase 3 study testing Polymyxin B in people with Trauma and Resistant Infection, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram negative infections. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Trauma, Resistant Infection, Critical Illness
- What is being tested?
- Polymyxin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 25 May 2017to 1 Dec 2019
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years or older admitted to the Intensive Care Unit of the Puerto Rico Trauma Hospital ° Consent form signed,
- Clinical and microbiological evidence of a MDR infection related to HAP, VAP, cUTI or BSI.
- The pathogen should be resistant to almost all antibiotics, AND/OR intermediate resistant to some of the antibiotics, AND/OR susceptible only to a class of antibiotic (i.e. aminoglycosides which are NOT recommended as monotherapy), AND/OR the clinician decision is to start the patient on polymyxin B due to severity of the infection.
- Patient with a diagnosis of MDR infection, who have not received antibiotics at all; OR if received would be < 72 hours with polymyxin B or imipenem at/or after the diagnosis of MDR AND/OR at the time of randomization
- Have a life expectancy of > 24 hours according to the attending physician's criteria.
Who cannot join
- Pregnant woman
- Prisoners
- Severe hepatic failure (defined by serum conjugated bilirubin > 3 mg/dL)
- End-stage renal disease requiring hemodialysis
- Hypersensitivity to any study drug
- Septic shock at the moment of randomization
- Died within 48 hours of starting the study
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site, 1 recruiting
- Recruiting
Trauma Hospital
San Juan, 00922-2129
Juan M Maldonado, Pharm D, 787-557-0612, juan.maldonado12@upr.edu
Pablo Rodriguez, MD, 787-4304415, pablororc@gmail.com
About this study
Official title: Polymyxin B Monotherapy Versus Polymyxin B-Carbapenem Combination Therapy in Critically Ill Patients With Multi-drug Resistant Gram-negative Infection: A Prospective, Parallel-Group, Double-Blind, Randomized Controlled Study
The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram negative infections. The investigators intend to evaluate if this synergistic drug regimen correlates with improved outcomes against gram-negative infections in critically ill patients including: better clinical resolution, reduced length of stay at hospital, reduced length of stay at the intensive care unit, and less recurrence of infection.
Read the detailed description
The "MUSEUM" trial is a single-center, prospective, parallel-group, double-blind, randomized, controlled study design. The trial will be conducted at the Intensive Care Unit of the Puerto Rico Trauma Hospital located in San Juan, Puerto Rico. Patients with clinical and microbiological evidence of an Multi-drug resistant infection related to Hospital-acquired pneumonia (HAP), Ventilator-associated pneumonia (VAP), Complicated Urinary tract infection (cUTI) or Bloodstream infection (BSI) will be considered candidates for the study. The pathogen should be resistant to all antibiotics except to polymyxin B. With a predicted survival rate of 67% (hazard ratio of 0.33), a significance of α = 0.05, power of 80%, and assuming a dropout rate of 15%, the estimated sample size is n = 40 patients (20 per group). In terms of safety, the most clinically relevant adverse effects are nephrotoxicity and neurotoxicity, which will be evaluated and adjudicated. The recurrence of infection will be defined as a new superinfection by the same or other species than the initial infection that is multidrug-resistant. Length of stay at the Hospital will be measured from the day of admission until the day of discharge. Length of stay in the ICU will be measured from the day of admission until the day of discharge from the unit. To our knowledge, this will be the first prospective, double blind, randomized, controlled clinical trial in representation of the critically ill trauma patients infected with Multi-drug resistant pathogens.
- Conditions
- Trauma, Resistant Infection, Critical Illness
- Being tested
- Polymyxin B
- Keywords
- Acinetobacter, Polymyxins, Imipenem, Pseudomona, Klebsiella
- Medical subject headings
- Wounds and Injuries, Critical Illness, Pseudomonas Infections, Klebsiella Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin BDrug
Also called Imipenem, (Primaxin)
Comparison of Poly B monotherapy vs Polymyxin B plus carbapenem in MDR infections
| Study group | Role | What they receive |
|---|---|---|
| Polymyxin B monotherapy | Other | Intravenous piggyback with Polymyxin B and control(Normal saline) Receives: Drug: Polymyxin B |
| Polymyxin B plus Carbapenem | Experimental | Intravenous piggyback with Polymyxin B plus Carbapenem Receives: Drug: Polymyxin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the evidence of clinical infection
Resolution of infection will be subjective to clinical criteria of the physician, AND patient has to be afebrile (temperature < 38°C), or normothermic (temperature 36-37.5°C), AND have white blood cell count within normal limits (> 4,000 and < 10,000 cells/mm3).
Measured: 7-14 days, according to site of infection
Secondary outcomes (4)
30-day mortality
Thirty-day (30-day) mortality will be measured from the day of hospital admission until discharge.
Measured: 30 days
Recurrence of infection
The recurrence of infection will be defined as a new superinfection by the same or other species than the initial infection that is multidrug-resistant.
Measured: 30 days
Length of stay at Hospital
Will be measured from the day of hospital admission until discharge.
Measured: 30 days
Length of stay at ICU.
Will be measured from the day of ICU admission until transfer or discharge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start25 May 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm with Polyxyxin B monotherapy and another arm with Polymyxin B plus carbapenem
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan M Maldonado Lozada, PharmD, Principal investigator, School of Pharmacy, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159078
- Sponsor's protocol ID
- B1210116
- Acronym
- MUSEUM
- Status last verified
- Feb 2019
- First submitted
- 10 May 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Struelens MJ. The epidemiology of antimicrobial resistance in hospital acquired infections: problems and possible solutions. BMJ. 1998 Sep 5;317(7159):652-4. doi: 10.1136/bmj.317.7159.652. No abstract available.
PubMed 9727997Sandri AM, Landersdorfer CB, Jacob J, Boniatti MM, Dalarosa MG, Falci DR, Behle TF, Bordinhao RC, Wang J, Forrest A, Nation RL, Li J, Zavascki AP. Population pharmacokinetics of intravenous polymyxin B in critically ill patients: implications for selection of dosage regimens. Clin Infect Dis. 2013 Aug;57(4):524-31. doi: 10.1093/cid/cit334. Epub 2013 May 22.
PubMed 23697744Zavascki AP, Bulitta JB, Landersdorfer CB. Combination therapy for carbapenem-resistant Gram-negative bacteria. Expert Rev Anti Infect Ther. 2013 Dec;11(12):1333-53. doi: 10.1586/14787210.2013.845523. Epub 2013 Nov 6.
PubMed 24191943Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.
PubMed 21793988Landman D, Georgescu C, Martin DA, Quale J. Polymyxins revisited. Clin Microbiol Rev. 2008 Jul;21(3):449-65. doi: 10.1128/CMR.00006-08.
PubMed 18625681Kassamali Z, Jain R, Danziger LH. An update on the arsenal for multidrug-resistant Acinetobacter infections: polymyxin antibiotics. Int J Infect Dis. 2015 Jan;30:125-32. doi: 10.1016/j.ijid.2014.10.014. Epub 2014 Nov 5.
PubMed 25461655Falagas ME, Rafailidis PI, Kasiakou SK, Hatzopoulou P, Michalopoulos A. Effectiveness and nephrotoxicity of colistin monotherapy vs. colistin-meropenem combination therapy for multidrug-resistant Gram-negative bacterial infections. Clin Microbiol Infect. 2006 Dec;12(12):1227-30. doi: 10.1111/j.1469-0691.2006.01559.x.
PubMed 17121631Rigatto MH, Vieira FJ, Antochevis LC, Behle TF, Lopes NT, Zavascki AP. Polymyxin B in Combination with Antimicrobials Lacking In Vitro Activity versus Polymyxin B in Monotherapy in Critically Ill Patients with Acinetobacter baumannii or Pseudomonas aeruginosa Infections. Antimicrob Agents Chemother. 2015 Oct;59(10):6575-80. doi: 10.1128/AAC.00494-15. Epub 2015 Aug 10.
PubMed 26259799Daikos GL, Tsaousi S, Tzouvelekis LS, Anyfantis I, Psichogiou M, Argyropoulou A, Stefanou I, Sypsa V, Miriagou V, Nepka M, Georgiadou S, Markogiannakis A, Goukos D, Skoutelis A. Carbapenemase-producing Klebsiella pneumoniae bloodstream infections: lowering mortality by antibiotic combination schemes and the role of carbapenems. Antimicrob Agents Chemother. 2014;58(4):2322-8. doi: 10.1128/AAC.02166-13. Epub 2014 Feb 10.
PubMed 24514083Tumbarello M, Viale P, Viscoli C, Trecarichi EM, Tumietto F, Marchese A, Spanu T, Ambretti S, Ginocchio F, Cristini F, Losito AR, Tedeschi S, Cauda R, Bassetti M. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis. 2012 Oct;55(7):943-50. doi: 10.1093/cid/cis588. Epub 2012 Jul 2.
PubMed 22752516Sobieszczyk ME, Furuya EY, Hay CM, Pancholi P, Della-Latta P, Hammer SM, Kubin CJ. Combination therapy with polymyxin B for the treatment of multidrug-resistant Gram-negative respiratory tract infections. J Antimicrob Chemother. 2004 Aug;54(2):566-9. doi: 10.1093/jac/dkh369. Epub 2004 Jul 21.
PubMed 15269195Anthony KB, Fishman NO, Linkin DR, Gasink LB, Edelstein PH, Lautenbach E. Clinical and microbiological outcomes of serious infections with multidrug-resistant gram-negative organisms treated with tigecycline. Clin Infect Dis. 2008 Feb 15;46(4):567-70. doi: 10.1086/526775.
PubMed 18199038Qureshi ZA, Paterson DL, Potoski BA, Kilayko MC, Sandovsky G, Sordillo E, Polsky B, Adams-Haduch JM, Doi Y. Treatment outcome of bacteremia due to KPC-producing Klebsiella pneumoniae: superiority of combination antimicrobial regimens. Antimicrob Agents Chemother. 2012 Apr;56(4):2108-13. doi: 10.1128/AAC.06268-11. Epub 2012 Jan 17.
PubMed 22252816Maragakis LL, Perl TM. Acinetobacter baumannii: epidemiology, antimicrobial resistance, and treatment options. Clin Infect Dis. 2008 Apr 15;46(8):1254-63. doi: 10.1086/529198.
PubMed 18444865Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
PubMed 27418577
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymyxin B Monotherapy Versus Polymyxin B-Carbapenem Combination Therapy in Critically Ill Patients With Multi-drug Resistant Gram-negative Infection: A Prospective, Parallel-Group, Double-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03159078
- Acronym / sponsor ID
- MUSEUM / B1210116
- Conditions
- Trauma, Resistant Infection, Critical Illness
- Keywords
- Acinetobacter, Polymyxins, Imipenem, Pseudomona, Klebsiella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram negative infections. The investigators intend to evaluate if this synergistic drug regimen correlates with improved outcomes against gram-negative infections in critically ill patients including: better clinical resolution, reduced length of stay at hospital, reduced length of stay at the intensive care unit, and less recurrence of infection.
Detailed description
The "MUSEUM" trial is a single-center, prospective, parallel-group, double-blind, randomized, controlled study design. The trial will be conducted at the Intensive Care Unit of the Puerto Rico Trauma Hospital located in San Juan, Puerto Rico. Patients with clinical and microbiological evidence of an Multi-drug resistant infection related to Hospital-acquired pneumonia (HAP), Ventilator-associated pneumonia (VAP), Complicated Urinary tract infection (cUTI) or Bloodstream infection (BSI) will be considered candidates for the study. The pathogen should be resistant to all antibiotics except to polymyxin B. With a predicted survival rate of 67% (hazard ratio of 0.33), a significance of α = 0.05, power of 80%, and assuming a dropout rate of 15%, the estimated sample size is n = 40 patients (20 per group). In terms of safety, the most clinically relevant adverse effects are nephrotoxicity and neurotoxicity, which will be evaluated and adjudicated. The recurrence of infection will be defined as a new superinfection by the same or other species than the initial infection that is multidrug-resistant. Length of stay at the Hospital will be measured from the day of admission until the day of discharge. Length of stay in the ICU will be measured from the day of admission until the day of discharge from the unit. To our knowledge, this will be the first prospective, double blind, randomized, controlled clinical trial in representation of the critically ill trauma patients infected with Multi-drug resistant pathogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One arm with Polyxyxin B monotherapy and another arm with Polymyxin B plus carbapenem
| Arm | Type | Receives |
|---|---|---|
| Polymyxin B monotherapy | Other | Drug: Polymyxin BIntravenous piggyback with Polymyxin B and control(Normal saline) |
| Polymyxin B plus Carbapenem | Experimental | Drug: Polymyxin BIntravenous piggyback with Polymyxin B plus Carbapenem |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years or older admitted to the Intensive Care Unit of the Puerto Rico Trauma Hospital ° Consent form signed,
- Clinical and microbiological evidence of a MDR infection related to HAP, VAP, cUTI or BSI.
- The pathogen should be resistant to almost all antibiotics, AND/OR intermediate resistant to some of the antibiotics, AND/OR susceptible only to a class of antibiotic (i.e. aminoglycosides which are NOT recommended as monotherapy), AND/OR the clinician decision is to start the patient on polymyxin B due to severity of the infection.
- Patient with a diagnosis of MDR infection, who have not received antibiotics at all; OR if received would be < 72 hours with polymyxin B or imipenem at/or after the diagnosis of MDR AND/OR at the time of randomization
- Have a life expectancy of > 24 hours according to the attending physician's criteria.
Key exclusion criteria (7 listed)
- Pregnant woman
- Prisoners
- Severe hepatic failure (defined by serum conjugated bilirubin > 3 mg/dL)
- End-stage renal disease requiring hemodialysis
- Hypersensitivity to any study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymyxin BAlso: Imipenem, (Primaxin)Comparison of Poly B monotherapy vs Polymyxin B plus carbapenem in MDR infections | Drug | Polymyxin B monotherapy, Polymyxin B plus Carbapenem |
Primary outcome
Resolution of the evidence of clinical infection
Time frame: 7-14 days, according to site of infection
Resolution of infection will be subjective to clinical criteria of the physician, AND patient has to be afebrile (temperature < 38°C), or normothermic (temperature 36-37.5°C), AND have white blood cell count within normal limits (> 4,000 and < 10,000 cells/mm3).
4 secondary outcomes
30-day mortality
Time frame: 30 days
Recurrence of infection
Time frame: 30 days
Length of stay at Hospital
Time frame: 30 days
Length of stay at ICU.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Results publication: PubMed 9727997Struelens MJ. The epidemiology of antimicrobial resistance in hospital acquired infections: problems and possible solutions. BMJ. 1998 Sep 5;317(7159):652-4. doi: 10.1136/bmj.317.7159.652. No abstract available.
- Results publication: PubMed 23697744Sandri AM, Landersdorfer CB, Jacob J, Boniatti MM, Dalarosa MG, Falci DR, Behle TF, Bordinhao RC, Wang J, Forrest A, Nation RL, Li J, Zavascki AP. Population pharmacokinetics of intravenous polymyxin B in critically ill patients: implications for selection of dosage regimens. Clin Infect Dis. 2013 Aug;57(4):524-31. doi: 10.1093/cid/cit334. Epub 2013 May 22.
- Results publication: PubMed 24191943Zavascki AP, Bulitta JB, Landersdorfer CB. Combination therapy for carbapenem-resistant Gram-negative bacteria. Expert Rev Anti Infect Ther. 2013 Dec;11(12):1333-53. doi: 10.1586/14787210.2013.845523. Epub 2013 Nov 6.
- Results publication: PubMed 21793988Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.
- Results publication: PubMed 18625681Landman D, Georgescu C, Martin DA, Quale J. Polymyxins revisited. Clin Microbiol Rev. 2008 Jul;21(3):449-65. doi: 10.1128/CMR.00006-08.
- Results publication: PubMed 25461655Kassamali Z, Jain R, Danziger LH. An update on the arsenal for multidrug-resistant Acinetobacter infections: polymyxin antibiotics. Int J Infect Dis. 2015 Jan;30:125-32. doi: 10.1016/j.ijid.2014.10.014. Epub 2014 Nov 5.
- Results publication: PubMed 17121631Falagas ME, Rafailidis PI, Kasiakou SK, Hatzopoulou P, Michalopoulos A. Effectiveness and nephrotoxicity of colistin monotherapy vs. colistin-meropenem combination therapy for multidrug-resistant Gram-negative bacterial infections. Clin Microbiol Infect. 2006 Dec;12(12):1227-30. doi: 10.1111/j.1469-0691.2006.01559.x.
- Results publication: PubMed 26259799Rigatto MH, Vieira FJ, Antochevis LC, Behle TF, Lopes NT, Zavascki AP. Polymyxin B in Combination with Antimicrobials Lacking In Vitro Activity versus Polymyxin B in Monotherapy in Critically Ill Patients with Acinetobacter baumannii or Pseudomonas aeruginosa Infections. Antimicrob Agents Chemother. 2015 Oct;59(10):6575-80. doi: 10.1128/AAC.00494-15. Epub 2015 Aug 10.
- Results publication: PubMed 24514083Daikos GL, Tsaousi S, Tzouvelekis LS, Anyfantis I, Psichogiou M, Argyropoulou A, Stefanou I, Sypsa V, Miriagou V, Nepka M, Georgiadou S, Markogiannakis A, Goukos D, Skoutelis A. Carbapenemase-producing Klebsiella pneumoniae bloodstream infections: lowering mortality by antibiotic combination schemes and the role of carbapenems. Antimicrob Agents Chemother. 2014;58(4):2322-8. doi: 10.1128/AAC.02166-13. Epub 2014 Feb 10.
- Results publication: PubMed 22752516Tumbarello M, Viale P, Viscoli C, Trecarichi EM, Tumietto F, Marchese A, Spanu T, Ambretti S, Ginocchio F, Cristini F, Losito AR, Tedeschi S, Cauda R, Bassetti M. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis. 2012 Oct;55(7):943-50. doi: 10.1093/cid/cis588. Epub 2012 Jul 2.
- Results publication: PubMed 15269195Sobieszczyk ME, Furuya EY, Hay CM, Pancholi P, Della-Latta P, Hammer SM, Kubin CJ. Combination therapy with polymyxin B for the treatment of multidrug-resistant Gram-negative respiratory tract infections. J Antimicrob Chemother. 2004 Aug;54(2):566-9. doi: 10.1093/jac/dkh369. Epub 2004 Jul 21.
- Results publication: PubMed 18199038Anthony KB, Fishman NO, Linkin DR, Gasink LB, Edelstein PH, Lautenbach E. Clinical and microbiological outcomes of serious infections with multidrug-resistant gram-negative organisms treated with tigecycline. Clin Infect Dis. 2008 Feb 15;46(4):567-70. doi: 10.1086/526775.
- Type of Healthcare-Associated InfectionsLink provided by the sponsor.
- Gram-negative Bacteria Infections in Healthcare SettingsLink provided by the sponsor.
- Trial for the Treatment of Extensively Drug-Resistant Gram-negative BacilliLink provided by the sponsor.
- Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus MeropenemLink provided by the sponsor.
- Primaxin I.V. (Imipenem and Cilastatin for IV Injection).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Maldonado Lozada, PharmD principal investigator
School of Pharmacy, University of Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polymyxin B in people with Trauma and Resistant Infection, run by University of Puerto Rico at 1 site in Puerto Rico.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Puerto Rico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan M Maldonado Lozada, Pharm D (7875570612, juan.maldonado12@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of the evidence of clinical infection (time frame: 7-14 days, according to site of infection). 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 NCT03159078, which also lists 21 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 8 Feb 2019.