Infective EndocarditisNCT04544306
Partial Oral Antimicrobials to Treat Infective Endocarditis in People Who Inject Drugs
A study testing Partial oral antimicrobial therapy in people with Infective Endocarditis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Infective endocarditis (IE) is a serious infection associated with significant morbidity and mortality. Recent studies demonstrated an increased risk of infective endocarditis in people who inject drugs (PWIDs). PWIDs have a high rate of non-compliance with hospital admissions and leaving against medical advice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Partial oral antimicrobial therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2021to 30 Jun 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years with self-reported intravenous drug use within 3 months of admission
- Transthoracic and/or transesophageal echocardiogram for IE diagnosis should be done within 48 hours of randomization
- Patients meet the modified Duke criteria for possible or definite infective endocarditis diagnosis
- Infection with an organism susceptible to at least two oral antimicrobial agents from different classes. In gram-negative bacterial endocarditis, susceptibility to fluoroquinolones only would be acceptable for inclusion
- Polymicrobial infections may be enrolled if an acceptable oral regimen can be constructed containing at least 2 agents against each gram-positive organism and one against each gram-negative
- Fungal Endocarditis may be enrolled if susceptibility to an oral azole is confirmed
- IE Patients who demonstrate improvement with initial intravenous therapy will be recruited
- Patients should receive a minimum of 10 days initial IV therapy and should have a minimum of 14 days remaining of their antimicrobial therapy
Who cannot join
- Undrained valvular, perivalvular, or cardiac abscess on echocardiogram studies
- Failure to show improvement to initial intravenous antimicrobial therapy
- Oral antibiotic malabsorption due to gastrointestinal disorders
- Acutely intoxicated patients who are not able to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Sarah Shalhoub, MD contact
Canada2 sites, 2 recruiting
- Recruiting
University Hospital
London, Ontario
Michael Silverman, MD,FRCP, 5196466100, michael.silverman@sjhc.london.on.ca
Sarah Shalhoub, MD, 5196466100, sarah.shalhoub@lhsc.on.ca
- Recruiting
Victoria Hospital
London, Ontario
Michael Silverman, MD,FRCP, michael.silverman@sjhc.london.on.ca
Sarah Shalhoub, MD
About this study
Official title: Partial Oral Antimicrobial Versus Intravenous Antimicrobial Therapy to Treat Infective Endocarditis in People Who Inject Drugs
Infective endocarditis (IE) is a serious infection associated with significant morbidity and mortality. Recent studies demonstrated an increased risk of infective endocarditis in people who inject drugs (PWIDs). PWIDs have a high rate of non-compliance with hospital admissions and leaving against medical advice. A recent landmark randomized controlled trial demonstrated similar outcomes when comparing partial oral antimicrobial therapy to continued intravenous antimicrobial therapy in the general population. Performing a trial to explore the non-inferiority of oral compared to intravenous antimicrobial therapy in PWIDs is essential in advancing patient care in this high risk increasing population.
Read the detailed description
This is a randomized open-label study. Participants will be randomized 1:1 in blocks of 5 to either continued intravenous antimicrobial therapy or oral antimicrobial therapy after a minimum of 10 days of IV therapy. The antimicrobial choice will be based on antimicrobial susceptibility. All oral regimens for gram-positive organisms will include 2 different agents. Gram-negative pathogens will be treated with oral quinolones if susceptibility results are compatible. Decisions regarding ongoing inpatient or outpatient therapy will be made at the discretion of the attending physician. Outpatient follow up will be once weekly for 6 weeks and then at 3 months. At each follow-up visit, participants will undergo a general physical exam, and their adherence to therapy and general wellbeing will be assessed as well. Blood samples will be sent for a complete blood count, creatinine, C-reactive protein by the investigators to ensure continued improvement in response to therapy. Within 72 hours of stopping therapy, a transthoracic echocardiogram will be performed to determine response to therapy and to establish a new baseline to which subsequent echocardiograms if medically indicated would be compared to assess for relapse or development of a new IE. All lab tests are done at our affiliated hospitals. Investigators plan first on performing a feasibility study. In the feasibility study, investigators recruit a total of 50 patients and randomize 25 in each arm. Baseline characteristics, of clinical interest with a potential impact on prognosis, and patients' outcomes will be compared using the Chi-square test for categorical variables and the t-test and the Mann-Whitney test for continuous variables, when appropriate. To examine the association between oral antimicrobial therapy and 90-day mortality, investigators plan to perform a multivariable logistic regression analysis with oral therapy being the independent variable. The model will also include variables of clinical interest: diabetes, renal impairment, immune-compromising condition, age > 50, and evidence of embolization.
- Conditions
- Infective Endocarditis
- Being tested
- Partial oral antimicrobial therapy
- Keywords
- PWID, oral antibiotics, endocarditis
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial oral antimicrobial therapyOther
Switch intravenous antimicrobial therapy to oral after an initial period of 10 days to oral antimicrobial therapy. Antimicrobial choices will be guided by antimicrobial susceptibilities.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of Care (intravenous antimicrobial therapy according to the American Heart Association Guideline 2015) |
| Partial oral treatment arm | Experimental | The mode of antimicrobial delivery is switched to oral therapy after at least 10 days of IV therapy, guided by antimicrobial susceptibility Receives: Other: Partial oral antimicrobial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of eligible participants who are approached for consent to participate will be recorded.
Number of individuals who are eligible to be enrolled during the study time frame.
Measured: 18 months
The percentage who consent for enrollment will be determined as well as the reasons for refusal.
Number of patients that participate as well as those who refuse to enroll during the study time frame.
Measured: 18 months
Secondary outcomes (2)
Percentage of enrolled patients for whom 90 day survival data is able to be confirmed.
Number of patients with all cause death or survival documented at 90 days post enrollment.
Measured: 3 months after randomization
Percentage of enrolled patients who continue in their assigned treatment arm (Oral or Parenteral) throughout the treatment interval.
The assessment of compliance with oral or parenteral antibiotics will be carried out during treatment.
Measured: 6 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jun 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Silverman, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael Silverman, MD,FRCP, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544306
- Sponsor's protocol ID
- 10418
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tookes H, Diaz C, Li H, Khalid R, Doblecki-Lewis S. A Cost Analysis of Hospitalizations for Infections Related to Injection Drug Use at a County Safety-Net Hospital in Miami, Florida. PLoS One. 2015 Jun 15;10(6):e0129360. doi: 10.1371/journal.pone.0129360. eCollection 2015.
PubMed 26075888Weir MA, Slater J, Jandoc R, Koivu S, Garg AX, Silverman M. The risk of infective endocarditis among people who inject drugs: a retrospective, population-based time series analysis. CMAJ. 2019 Jan 28;191(4):E93-E99. doi: 10.1503/cmaj.180694.
PubMed 30692105Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28.
PubMed 30152252Kasper KJ, Manoharan I, Hallam B, Coleman CE, Koivu SL, Weir MA, McCormick JK, Silverman MS. A controlled-release oral opioid supports S. aureus survival in injection drug preparation equipment and may increase bacteremia and endocarditis risk. PLoS One. 2019 Aug 9;14(8):e0219777. doi: 10.1371/journal.pone.0219777. eCollection 2019.
PubMed 31398210Rodger L, Glockler-Lauf SD, Shojaei E, Sherazi A, Hallam B, Koivu S, Gupta K, Hosseini-Moghaddam SM, Silverman M. Clinical Characteristics and Factors Associated With Mortality in First-Episode Infective Endocarditis Among Persons Who Inject Drugs. JAMA Netw Open. 2018 Nov 2;1(7):e185220. doi: 10.1001/jamanetworkopen.2018.5220.
PubMed 30646383Rodger L, Shah M, Shojaei E, Hosseini S, Koivu S, Silverman M. Recurrent Endocarditis in Persons Who Inject Drugs. Open Forum Infect Dis. 2019 Sep 9;6(10):ofz396. doi: 10.1093/ofid/ofz396. eCollection 2019 Oct.
PubMed 31660358Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.
PubMed 26373316Heldman AW, Hartert TV, Ray SC, Daoud EG, Kowalski TE, Pompili VJ, Sisson SD, Tidmore WC, vom Eigen KA, Goodman SN, Lietman PS, Petty BG, Flexner C. Oral antibiotic treatment of right-sided staphylococcal endocarditis in injection drug users: prospective randomized comparison with parenteral therapy. Am J Med. 1996 Jul;101(1):68-76. doi: 10.1016/s0002-9343(96)00070-8.
PubMed 8686718Al-Omari A, Cameron DW, Lee C, Corrales-Medina VF. Oral antibiotic therapy for the treatment of infective endocarditis: a systematic review. BMC Infect Dis. 2014 Mar 13;14:140. doi: 10.1186/1471-2334-14-140.
PubMed 24624933Tissot-Dupont H, Gouriet F, Oliver L, Jamme M, Casalta JP, Jimeno MT, Arregle F, Lavoute C, Hubert S, Philip M, Martel H, Riberi A, Habib G, Raoult D. High-dose trimethoprim-sulfamethoxazole and clindamycin for Staphylococcus aureus endocarditis. Int J Antimicrob Agents. 2019 Aug;54(2):143-148. doi: 10.1016/j.ijantimicag.2019.06.006. Epub 2019 Jun 8.
PubMed 31181351Suzuki J, Johnson J, Montgomery M, Hayden M, Price C. Outpatient Parenteral Antimicrobial Therapy Among People Who Inject Drugs: A Review of the Literature. Open Forum Infect Dis. 2018 Aug 7;5(9):ofy194. doi: 10.1093/ofid/ofy194. eCollection 2018 Sep.
PubMed 30211247Eaton EF, Mathews RE, Lane PS, Paddock CS, Rodriguez JM, Taylor BB, Saag MS, Kilgore ML, Lee RA. A 9-Point Risk Assessment for Patients Who Inject Drugs and Require Intravenous Antibiotics: Focusing Inpatient Resources on Patients at Greatest Risk of Ongoing Drug Use. Clin Infect Dis. 2019 Mar 5;68(6):1041-1043. doi: 10.1093/cid/ciy722.
PubMed 30165395Beieler AM, Dellit TH, Chan JD, Dhanireddy S, Enzian LK, Stone TJ, Dwyer-O'Connor E, Lynch JB. Successful implementation of outpatient parenteral antimicrobial therapy at a medical respite facility for homeless patients. J Hosp Med. 2016 Aug;11(8):531-5. doi: 10.1002/jhm.2597. Epub 2016 Apr 27.
PubMed 27120700Norris AH, Shrestha NK, Allison GM, Keller SC, Bhavan KP, Zurlo JJ, Hersh AL, Gorski LA, Bosso JA, Rathore MH, Arrieta A, Petrak RM, Shah A, Brown RB, Knight SL, Umscheid CA. 2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy. Clin Infect Dis. 2019 Jan 1;68(1):e1-e35. doi: 10.1093/cid/ciy745.
PubMed 30423035Silverman M, Slater J, Jandoc R, Koivu S, Garg AX, Weir MA. Hydromorphone and the risk of infective endocarditis among people who inject drugs: a population-based, retrospective cohort study. Lancet Infect Dis. 2020 Apr;20(4):487-497. doi: 10.1016/S1473-3099(19)30705-4. Epub 2020 Jan 22.
PubMed 31981474
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Oral Antimicrobial Versus Intravenous Antimicrobial Therapy to Treat Infective Endocarditis in People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT04544306
- Acronym / sponsor ID
- 10418
- Conditions
- Infective Endocarditis
- Keywords
- PWID, oral antibiotics, endocarditis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Sep 2020 (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.
Infective endocarditis (IE) is a serious infection associated with significant morbidity and mortality. Recent studies demonstrated an increased risk of infective endocarditis in people who inject drugs (PWIDs). PWIDs have a high rate of non-compliance with hospital admissions and leaving against medical advice. A recent landmark randomized controlled trial demonstrated similar outcomes when comparing partial oral antimicrobial therapy to continued intravenous antimicrobial therapy in the general population. Performing a trial to explore the non-inferiority of oral compared to intravenous antimicrobial therapy in PWIDs is essential in advancing patient care in this high risk increasing population.
Detailed description
This is a randomized open-label study. Participants will be randomized 1:1 in blocks of 5 to either continued intravenous antimicrobial therapy or oral antimicrobial therapy after a minimum of 10 days of IV therapy. The antimicrobial choice will be based on antimicrobial susceptibility. All oral regimens for gram-positive organisms will include 2 different agents. Gram-negative pathogens will be treated with oral quinolones if susceptibility results are compatible. Decisions regarding ongoing inpatient or outpatient therapy will be made at the discretion of the attending physician. Outpatient follow up will be once weekly for 6 weeks and then at 3 months. At each follow-up visit, participants will undergo a general physical exam, and their adherence to therapy and general wellbeing will be assessed as well. Blood samples will be sent for a complete blood count, creatinine, C-reactive protein by the investigators to ensure continued improvement in response to therapy. Within 72 hours of stopping therapy, a transthoracic echocardiogram will be performed to determine response to therapy and to establish a new baseline to which subsequent echocardiograms if medically indicated would be compared to assess for relapse or development of a new IE. All lab tests are done at our affiliated hospitals. Investigators plan first on performing a feasibility study. In the feasibility study, investigators recruit a total of 50 patients and randomize 25 in each arm. Baseline characteristics, of clinical interest with a potential impact on prognosis, and patients' outcomes will be compared using the Chi-square test for categorical variables and the t-test and the Mann-Whitney test for continuous variables, when appropriate. To examine the association between oral antimicrobial therapy and 90-day mortality, investigators plan to perform a multivariable logistic regression analysis with oral therapy being the independent variable. The model will also include variables of clinical interest: diabetes, renal impairment, immune-compromising condition, age > 50, and evidence of embolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Standard of Care (intravenous antimicrobial therapy according to the American Heart Association Guideline 2015) |
| Partial oral treatment arm | Experimental | Other: Partial oral antimicrobial therapyThe mode of antimicrobial delivery is switched to oral therapy after at least 10 days of IV therapy, guided by antimicrobial susceptibility |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults ≥ 18 years with self-reported intravenous drug use within 3 months of admission
- Transthoracic and/or transesophageal echocardiogram for IE diagnosis should be done within 48 hours of randomization
- Patients meet the modified Duke criteria for possible or definite infective endocarditis diagnosis
- Infection with an organism susceptible to at least two oral antimicrobial agents from different classes. In gram-negative bacterial endocarditis, susceptibility to fluoroquinolones only would be acceptable for inclusion
- Polymicrobial infections may be enrolled if an acceptable oral regimen can be constructed containing at least 2 agents against each gram-positive organism and one against each gram-negative
Key exclusion criteria (4 listed)
- Undrained valvular, perivalvular, or cardiac abscess on echocardiogram studies
- Failure to show improvement to initial intravenous antimicrobial therapy
- Oral antibiotic malabsorption due to gastrointestinal disorders
- Acutely intoxicated patients who are not able to provide informed consent
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 |
|---|---|---|
| Partial oral antimicrobial therapySwitch intravenous antimicrobial therapy to oral after an initial period of 10 days to oral antimicrobial therapy. Antimicrobial choices will be guided by antimicrobial susceptibilities. | Other | Partial oral treatment arm |
Primary outcome
The number of eligible participants who are approached for consent to participate will be recorded.
Time frame: 18 months
Number of individuals who are eligible to be enrolled during the study time frame.
The percentage who consent for enrollment will be determined as well as the reasons for refusal.
Time frame: 18 months
Number of patients that participate as well as those who refuse to enroll during the study time frame.
2 secondary outcomes
Percentage of enrolled patients for whom 90 day survival data is able to be confirmed.
Time frame: 3 months after randomization
Percentage of enrolled patients who continue in their assigned treatment arm (Oral or Parenteral) throughout the treatment interval.
Time frame: 6 weeks post enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 26075888Tookes H, Diaz C, Li H, Khalid R, Doblecki-Lewis S. A Cost Analysis of Hospitalizations for Infections Related to Injection Drug Use at a County Safety-Net Hospital in Miami, Florida. PLoS One. 2015 Jun 15;10(6):e0129360. doi: 10.1371/journal.pone.0129360. eCollection 2015.
- Background: PubMed 30692105Weir MA, Slater J, Jandoc R, Koivu S, Garg AX, Silverman M. The risk of infective endocarditis among people who inject drugs: a retrospective, population-based time series analysis. CMAJ. 2019 Jan 28;191(4):E93-E99. doi: 10.1503/cmaj.180694.
- Background: PubMed 30152252Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28.
- Background: PubMed 31398210Kasper KJ, Manoharan I, Hallam B, Coleman CE, Koivu SL, Weir MA, McCormick JK, Silverman MS. A controlled-release oral opioid supports S. aureus survival in injection drug preparation equipment and may increase bacteremia and endocarditis risk. PLoS One. 2019 Aug 9;14(8):e0219777. doi: 10.1371/journal.pone.0219777. eCollection 2019.
- Background: PubMed 30646383Rodger L, Glockler-Lauf SD, Shojaei E, Sherazi A, Hallam B, Koivu S, Gupta K, Hosseini-Moghaddam SM, Silverman M. Clinical Characteristics and Factors Associated With Mortality in First-Episode Infective Endocarditis Among Persons Who Inject Drugs. JAMA Netw Open. 2018 Nov 2;1(7):e185220. doi: 10.1001/jamanetworkopen.2018.5220.
- Background: PubMed 31660358Rodger L, Shah M, Shojaei E, Hosseini S, Koivu S, Silverman M. Recurrent Endocarditis in Persons Who Inject Drugs. Open Forum Infect Dis. 2019 Sep 9;6(10):ofz396. doi: 10.1093/ofid/ofz396. eCollection 2019 Oct.
- Background: PubMed 26373316Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.
- Background: PubMed 8686718Heldman AW, Hartert TV, Ray SC, Daoud EG, Kowalski TE, Pompili VJ, Sisson SD, Tidmore WC, vom Eigen KA, Goodman SN, Lietman PS, Petty BG, Flexner C. Oral antibiotic treatment of right-sided staphylococcal endocarditis in injection drug users: prospective randomized comparison with parenteral therapy. Am J Med. 1996 Jul;101(1):68-76. doi: 10.1016/s0002-9343(96)00070-8.
- Background: PubMed 24624933Al-Omari A, Cameron DW, Lee C, Corrales-Medina VF. Oral antibiotic therapy for the treatment of infective endocarditis: a systematic review. BMC Infect Dis. 2014 Mar 13;14:140. doi: 10.1186/1471-2334-14-140.
- Background: PubMed 31181351Tissot-Dupont H, Gouriet F, Oliver L, Jamme M, Casalta JP, Jimeno MT, Arregle F, Lavoute C, Hubert S, Philip M, Martel H, Riberi A, Habib G, Raoult D. High-dose trimethoprim-sulfamethoxazole and clindamycin for Staphylococcus aureus endocarditis. Int J Antimicrob Agents. 2019 Aug;54(2):143-148. doi: 10.1016/j.ijantimicag.2019.06.006. Epub 2019 Jun 8.
- Background: PubMed 30211247Suzuki J, Johnson J, Montgomery M, Hayden M, Price C. Outpatient Parenteral Antimicrobial Therapy Among People Who Inject Drugs: A Review of the Literature. Open Forum Infect Dis. 2018 Aug 7;5(9):ofy194. doi: 10.1093/ofid/ofy194. eCollection 2018 Sep.
- Background: PubMed 30165395Eaton EF, Mathews RE, Lane PS, Paddock CS, Rodriguez JM, Taylor BB, Saag MS, Kilgore ML, Lee RA. A 9-Point Risk Assessment for Patients Who Inject Drugs and Require Intravenous Antibiotics: Focusing Inpatient Resources on Patients at Greatest Risk of Ongoing Drug Use. Clin Infect Dis. 2019 Mar 5;68(6):1041-1043. doi: 10.1093/cid/ciy722.
- 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.
Sarah Shalhoub, MD contact
Michael Silverman, MD,FRCP principal investigator
LHSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial oral antimicrobial therapy in people with Infective Endocarditis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 8 inclusion and 4 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Silverman, MD,FRCP (5196466100, michael.silverman@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of eligible participants who are approached for consent to participate will be recorded. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT04544306, which also lists 18 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 26 Feb 2024.