NephrotoxicityNCT07818265
Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-C
An observational study of Nephrotoxicity and Bacterial Infections, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
This prospective comparative observational study will compare the incidence of true nephrotoxicity in adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotoxicity, Bacterial Infections, Acute Kidney Injury
- How many people
- 304 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Sep 2026to 9 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients admitted to King Faisal Specialist Hospital and Research Center, and received vancomycin combined with either piperacillin-tazobactam or meropenem from August 2026 until achieving the pre-specified sample size will be screened for the inclusion and exclusion criteria
Who may be able to join
- Age ≥18 years.
- Receipt of vancomycin in combination with either piperacillin-tazobactam or meropenem, with both antimicrobial agents prescribed by the treating physician and expected to be administered concomitantly for >48 hours.
Who cannot join
- Known advanced chronic kidney disease (CKD), defined as a baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or dialysis dependence..
- Pregnancy.
- Receipt of renal replacement therapy prior to enrollment.
- Obstructive uropathy causing AKI.
- Recipients of solid organ transplant or hematopoietic stem cell transplantation within one year of presentation
- Concomitant receive of agents known to be nephrotoxins:
Show all 10Show fewer
- Amphotericin B Aminoglycosides Calcineurin inhibitors
- Patients with AKI 30 days prior to vancomycin initiation
- Admission to the ICU for indication other than postoperative care for > 72 hours
- Receiving vancomycin therapy within 30 days before the index combination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Center-Riyadh
Riyadh, 11211
Hakeam Hakeam, MS Pharm, +9664647272 ext. 38611, hakeam@kfshrc.edu.sa
A
About this study
This prospective comparative observational study will compare the incidence of true nephrotoxicity in adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem.
Vancomycin plus piperacillin-tazobactam has been associated with a higher incidence of kidney injury based mainly on increases in serum creatinine. However, it remains uncertain whether these increases represent true kidney injury or pseudo-nephrotoxicity, in which serum creatinine increases without a corresponding decline in kidney function.
Read more
To address this uncertainty, the study will prospectively assess kidney function using both serum creatinine and cystatin C. True nephrotoxicity will be identified when changes in both biomarkers meet the study criteria for acute kidney injury, while an increase in serum creatinine without a corresponding cystatin C increase will be considered pseudo-nephrotoxicity.
The study will compare true nephrotoxicity between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem. It will also evaluate the timing, persistence, severity, and recovery of kidney injury. The results may help clarify whether the higher rates of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represent true renal injury and may help guide antibiotic selection when balancing antimicrobial coverage and kidney safety.
Read the detailed description
Vancomycin is commonly administered in combination with broad-spectrum beta-lactam antibiotics for empiric treatment of serious infections. Several studies have reported a higher incidence of nephrotoxicity in patients receiving vancomycin plus piperacillin-tazobactam compared with vancomycin combined with other antipseudomonal beta-lactams. However, most of these studies have defined kidney injury using serum creatinine alone. This has raised concern that the observed increase in nephrotoxicity may, at least in part, represent pseudo-nephrotoxicity caused by an increase in serum creatinine without a corresponding reduction in true kidney function.
This prospective, non-interventional, comparative two-arm cohort study will evaluate adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem. Treatment selection, antimicrobial dosing, vancomycin therapeutic drug monitoring, fluid management, hemodynamic management, and other clinical decisions will remain under the responsibility of the treating clinical team and will not be determined by the study investigators.
The primary objective is to compare the incidence of true nephrotoxicity between the two treatment groups. Kidney function will be assessed prospectively using both serum creatinine and cystatin C. True nephrotoxicity will be defined as fulfillment of the study criteria for acute kidney injury using both serum creatinine and cystatin C, whereas pseudo-nephrotoxicity will be defined as serum creatinine-based acute kidney injury without a corresponding increase in cystatin C.
Serum creatinine and cystatin C will be assessed at baseline and serially during combination antimicrobial therapy, with additional follow-up measurements after discontinuation when available according to the study protocol. This simultaneous biomarker assessment is intended to help distinguish functional changes in serum creatinine from kidney injury supported by a parallel change in cystatin C.
Secondary assessments will include the time to onset of acute kidney injury based separately on serum creatinine and cystatin C, the incidence of transient and persistent acute kidney injury, kidney recovery, and the severity of acute kidney injury. Kidney recovery and progression to acute kidney disease will also be assessed during follow-up when applicable.
Patients will be categorized into two observational exposure groups according to the beta-lactam prescribed by the treating team: vancomycin plus piperacillin-tazobactam or vancomycin plus meropenem. Relevant demographic, clinical, laboratory, antimicrobial exposure, and potential nephrotoxic risk factors will be prospectively collected.
The study is designed to clarify whether the higher incidence of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represents true renal injury or predominantly a serum creatinine-based phenomenon. The findings may improve interpretation of kidney function during antibiotic therapy and may help clinicians balance antimicrobial coverage with the risk of nephrotoxicity when selecting empiric antibiotic regimens.
- Keywords
- Piperacillin tazobactam, Nephrotoxicity, Vancomycin, Meropenem, Cystatin-c, serum creatinine
- Medical subject headings
- Bacterial Infections, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin - Piperacillin Tazobactam | Patients who will be receiving a combination of vancomycin and piperacillin-tazobactam for treating various types of infections | |
| Vancomycin - Meropenem | Patients who will be receiving a combination of vancomycin and meropenem for treating various types of infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of developing true nephrotoxicity in patients receiving vancomycin + piperacillin-tazobactam versus vancomycin + meropenem.
True nephrotoxicity is defined as both serum creatinine and cystatin-C meet the AKI criteria on 2026 KDIGO criteria.
Serum creatinine-based AKI: defined as any of the following: Change in SCr≥0.3 mg/dL within 48 hours OR SCr≥1.5×baseline within 7 days.
Cystatin-C-Based AKI is defined as any of the following: ≥50% increase from baseline cystatin-C OR absolute increase ≥0.3 mg/L from baseline
Measured: From enrollment until 72 hours from stopping vancomycin therapy
Secondary outcomes (4)
Difference in time to AKI onset based on serum creatinine and cystatin C between the two groups
Time to AKI onset will be determined independently according to serum creatinine-based and cystatin C-based AKI criteria.
Time to AKI onset will be calculated from initiation of the study antibiotic regimen to the first time the participant meets the respective AKI criterion. The difference in time to AKI onset between serum creatinine-based and cystatin C-based assessments will be evaluated and compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.
Measured: From enrollment until 72 hours from stopping vancomycin
Incidence of Transient and Persistent Acute Kidney Injury According to the 2026 KDIGO Criteria between the two study groups
AKI will be classified as transient or persistent according to the 2026 KDIGO AKI/AKD criteria based on the duration of increased serum creatinine or cystatin C, or reduced urine output. The incidence of transient and persistent AKI will be compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.
Measured: From enrollment until 72 hours from vancomycin therapy cessation
Recovery from AKI according to the 2026 KDIGO Criteria
Recovery from AKI will be assessed according to the 2026 KDIGO AKI/AKD criteria using serum creatinine-based and cystatin C-based assessments. The proportion of participants achieving recovery from AKI will be determined and compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.
Measured: From AKI onset through 90 days after AKI onset.
Severity of AKI staged according to the 2026 KDIGO criteria between the two groups
The severity of acute kidney injury (AKI) will be assessed according to the 2026 Kidney Disease: Improving Global Outcomes (KDIGO) AKI/AKD criteria. Participants who develop AKI will be classified according to AKI severity (Stage 1, Stage 2, or Stage 3) based on serum creatinine and urine output criteria. The distribution of AKI severity stages will be compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.
Measured: From AKI onset through 7 days after AKI onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion5 Jun 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrotoxicityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakeam Abdulaziz Hakeam, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818265
- Sponsor's protocol ID
- IRB#2261314
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
1. Lewington AJ, Cerda J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84:457-467. 2. Perazella MA, Rosner MH. Drug-Induced Acute Kidney Injury. Clin J Am Soc Nephrol. 2022;17:1220-1233. 3. Fresilli S, Labanca R, Losiggio R, et al. Long-Term Outcomes After Acute Kidney Injury During Hospitalization: A Systematic Review and Meta-Analysis of Matched Controls Studies. Crit Care Med. 2026;54:335-342. 4. Pan K, Li R, Li Y, Ding X, Li X, Lv Q. Vancomycin combined with piperacillin/tazobactam increases the risk of acute kidney injury compared with vancomycin plus other anti-pseudomonal beta-lactams: a systematic review and network meta-analysis. J Antimicrob Chemother. 2025;80:47-58. 5. Prescott HC, Antonelli M, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2026. Crit Care Med. 2026;54:725-812. 6. Kalil AC, Metersky ML, Klompas M, et al. 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;63:e61-e111. 7. Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e10-52. 8. Chiu CY, Sarwal A. Evaluating the Nephrotoxicity of Area-under-the-Curve-Based Dosing of Vancomycin with Concomitant Antipseudomonal Beta-Lactam Antibiotics: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023;59. 9. Rutter WC, Cox JN, Martin CA, Burgess DR, Burgess DS. Nephrotoxicity during Vancomycin Therapy in Combination with Piperacillin-Tazobactam or Cefepime. Antimicrob Agents Chemother. 2017;61. 10. Miano TA, Hennessy S, Yang W, et al. Association of vancomycin plus piperacillin-tazobactam
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-C
- ClinicalTrials.gov ID
- NCT07818265
- Acronym / sponsor ID
- IRB#2261314
- Keywords
- Piperacillin tazobactam, Nephrotoxicity, Vancomycin, Meropenem, Cystatin-c, serum creatinine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
This prospective comparative observational study will compare the incidence of true nephrotoxicity in adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem.
Vancomycin plus piperacillin-tazobactam has been associated with a higher incidence of kidney injury based mainly on increases in serum creatinine. However, it remains uncertain whether these increases represent true kidney injury or pseudo-nephrotoxicity, in which serum creatinine increases without a corresponding decline in kidney function.
To address this uncertainty, the study will prospectively assess kidney function using both serum creatinine and cystatin C. True nephrotoxicity will be identified when changes in both biomarkers meet the study criteria for acute kidney injury, while an increase in serum creatinine without a corresponding cystatin C increase will be considered pseudo-nephrotoxicity.
The study will compare true nephrotoxicity between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem. It will also evaluate the timing, persistence, severity, and recovery of kidney injury. The results may help clarify whether the higher rates of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represent true renal injury and may help guide antibiotic selection when balancing antimicrobial coverage and kidney safety.
Detailed description
Vancomycin is commonly administered in combination with broad-spectrum beta-lactam antibiotics for empiric treatment of serious infections. Several studies have reported a higher incidence of nephrotoxicity in patients receiving vancomycin plus piperacillin-tazobactam compared with vancomycin combined with other antipseudomonal beta-lactams. However, most of these studies have defined kidney injury using serum creatinine alone. This has raised concern that the observed increase in nephrotoxicity may, at least in part, represent pseudo-nephrotoxicity caused by an increase in serum creatinine without a corresponding reduction in true kidney function.
This prospective, non-interventional, comparative two-arm cohort study will evaluate adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem. Treatment selection, antimicrobial dosing, vancomycin therapeutic drug monitoring, fluid management, hemodynamic management, and other clinical decisions will remain under the responsibility of the treating clinical team and will not be determined by the study investigators.
The primary objective is to compare the incidence of true nephrotoxicity between the two treatment groups. Kidney function will be assessed prospectively using both serum creatinine and cystatin C. True nephrotoxicity will be defined as fulfillment of the study criteria for acute kidney injury using both serum creatinine and cystatin C, whereas pseudo-nephrotoxicity will be defined as serum creatinine-based acute kidney injury without a corresponding increase in cystatin C.
Serum creatinine and cystatin C will be assessed at baseline and serially during combination antimicrobial therapy, with additional follow-up measurements after discontinuation when available according to the study protocol. This simultaneous biomarker assessment is intended to help distinguish functional changes in serum creatinine from kidney injury supported by a parallel change in cystatin C.
Secondary assessments will include the time to onset of acute kidney injury based separately on serum creatinine and cystatin C, the incidence of transient and persistent acute kidney injury, kidney recovery, and the severity of acute kidney injury. Kidney recovery and progression to acute kidney disease will also be assessed during follow-up when applicable.
Patients will be categorized into two observational exposure groups according to the beta-lactam prescribed by the treating team: vancomycin plus piperacillin-tazobactam or vancomycin plus meropenem. Relevant demographic, clinical, laboratory, antimicrobial exposure, and potential nephrotoxic risk factors will be prospectively collected.
The study is designed to clarify whether the higher incidence of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represents true renal injury or predominantly a serum creatinine-based phenomenon. The findings may improve interpretation of kidney function during antibiotic therapy and may help clinicians balance antimicrobial coverage with the risk of nephrotoxicity when selecting empiric antibiotic regimens.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin - Piperacillin Tazobactam | – | –Patients who will be receiving a combination of vancomycin and piperacillin-tazobactam for treating various types of infections |
| Vancomycin - Meropenem | – | –Patients who will be receiving a combination of vancomycin and meropenem for treating various types of infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to King Faisal Specialist Hospital and Research Center, and received vancomycin combined with either piperacillin-tazobactam or meropenem from August 2026 until achieving the pre-specified sample size will be screened for the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Age ≥18 years.
- Receipt of vancomycin in combination with either piperacillin-tazobactam or meropenem, with both antimicrobial agents prescribed by the treating physician and expected to be administered concomitantly for >48 hours.
Key exclusion criteria (10 listed)
- Known advanced chronic kidney disease (CKD), defined as a baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or dialysis dependence..
- Pregnancy.
- Receipt of renal replacement therapy prior to enrollment.
- Obstructive uropathy causing AKI.
- Recipients of solid organ transplant or hematopoietic stem cell transplantation within one year of presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the incidence of developing true nephrotoxicity in patients receiving vancomycin + piperacillin-tazobactam versus vancomycin + meropenem.
Time frame: From enrollment until 72 hours from stopping vancomycin therapy
True nephrotoxicity is defined as both serum creatinine and cystatin-C meet the AKI criteria on 2026 KDIGO criteria. Serum creatinine-based AKI: defined as any of the following: Change in SCr≥0.3 mg/dL within 48 hours OR SCr≥1.5×baseline within 7 days. Cystatin-C-Based AKI is defined as any of the following: ≥50% increase from baseline cystatin-C OR absolute increase ≥0.3 mg/L from baseline
4 secondary outcomes
Difference in time to AKI onset based on serum creatinine and cystatin C between the two groups
Time frame: From enrollment until 72 hours from stopping vancomycin
Incidence of Transient and Persistent Acute Kidney Injury According to the 2026 KDIGO Criteria between the two study groups
Time frame: From enrollment until 72 hours from vancomycin therapy cessation
Recovery from AKI according to the 2026 KDIGO Criteria
Time frame: From AKI onset through 90 days after AKI onset.
Severity of AKI staged according to the 2026 KDIGO criteria between the two groups
Time frame: From AKI onset through 7 days after AKI onset.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background1. Lewington AJ, Cerda J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84:457-467. 2. Perazella MA, Rosner MH. Drug-Induced Acute Kidney Injury. Clin J Am Soc Nephrol. 2022;17:1220-1233. 3. Fresilli S, Labanca R, Losiggio R, et al. Long-Term Outcomes After Acute Kidney Injury During Hospitalization: A Systematic Review and Meta-Analysis of Matched Controls Studies. Crit Care Med. 2026;54:335-342. 4. Pan K, Li R, Li Y, Ding X, Li X, Lv Q. Vancomycin combined with piperacillin/tazobactam increases the risk of acute kidney injury compared with vancomycin plus other anti-pseudomonal beta-lactams: a systematic review and network meta-analysis. J Antimicrob Chemother. 2025;80:47-58. 5. Prescott HC, Antonelli M, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2026. Crit Care Med. 2026;54:725-812. 6. Kalil AC, Metersky ML, Klompas M, et al. 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;63:e61-e111. 7. Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e10-52. 8. Chiu CY, Sarwal A. Evaluating the Nephrotoxicity of Area-under-the-Curve-Based Dosing of Vancomycin with Concomitant Antipseudomonal Beta-Lactam Antibiotics: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023;59. 9. Rutter WC, Cox JN, Martin CA, Burgess DR, Burgess DS. Nephrotoxicity during Vancomycin Therapy in Combination with Piperacillin-Tazobactam or Cefepime. Antimicrob Agents Chemother. 2017;61. 10. Miano TA, Hennessy S, Yang W, et al. Association of vancomycin plus piperacillin-tazobactam
- Individual participant dataSharing planned: No
Related trials for Nephrotoxicity
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
Biomarkers, Acute Kidney Injury
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Active, not recruitingPhase 3
Cisplatin Disposition and Kidney Injury
Nephrotoxicity
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotoxicity and Bacterial Infections, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 10 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hakeam A Hakeam, MS Pharm., BCPS (+966505494897, hakeam@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of developing true nephrotoxicity in patients receiving vancomycin + piperacillin-tazobactam versus vancomycin + meropenem. (time frame: From enrollment until 72 hours from stopping vancomycin therapy). 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 NCT07818265, which also lists 1 linked publication.
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 14 Sep 2026.