Severe InfectionPhase 4ZAVICONTNCT06811727

CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients

A Phase 4 study testing Continuos ceftazidime/avibactam infusion and Intermitent dosing as per SMPC in people with Severe Infection, run by Ivan Šitum, MD at 1 site in Croatia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Severe Infection
What is being tested?: Continuos ceftazidime/avibactam infusion and Intermitent dosing as per SMPC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteCroatia
Study dates: 1 Aug 2025to 1 Aug 2029
Phase: Phase 4
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

General
Age above or equal to 18 years of age.
Able to provide informed consent personally or by his/her next of kin, as requested by the Ethics Committee.
Disease-specific
Critically ill patients requiring admission to the intensive care unit (medical or surgical).
Diagnosed with severe infections.
At least one microbiological sample positive for Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa.
Requiring a prescription for ceftazidime/avibactam, by clinical judgement

Who cannot join

General
Known or suspected hypersensitivity to ceftazidime/avibactam, excipients, or any other cephalosporin antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
Withdrawal of informed consent.
Age above 85 years of age.
Female who is pregnant or breast-feeding.
Participation (i.e. signed informed consent) in any other interventional clinical trial of an approved or non-approved antibacterial agent within 30 days before screening.

Show all 14Show fewer

Any disorder which, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
Laboratory values
1. Severe neutropenia before or during ceftazidime/avibactam administration.
Medical conditions
Death within 48 hours following randomization.
Concomitant acquired immunodeficiency syndrome.
Presence or history of malignant neoplasms or in situ carcinomas.
Duration of ceftazidime/avibactam administration is shorter than 72 hours.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ivan Šitum, MD contact

0915143620

ivsitum@gmail.com

Daniel Lovrić, MD, PhD contact

385914488350

daniel@lovric.net

Croatia1 site, 1 recruiting

UHC ZAgreb
Zagreb, 10000
Daniel Lovrić, assist. prof., 0914488350, daniel@dlovric.net
Recruiting

Other trials in Croatia

About this study

Official title: CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients With Klebsiella Pneumoniae OXA-48 or Pseudomonas Aeruginosa Infections: A Single-centre Randomized Open-label Trial (ZAVICONT)

Ceftazidime/avibactam (CZA) is an essential treatment option for managing infections caused by multidrug-resistant (MDR) gram-negative (G-) bacteria, including Klebsiella pneumoniae OXA-48 and carbapenem-resistant Pseudomonas aeruginosa. Critically ill intensive care unit (ICU) patients frequently exhibit altered pharmacokinetics (PK) of CZA, potentially compromising optimal PK/pharmacodynamic (PD) target attainment with standard dosing regimens. This study compares the efficacy of continuous infusion (CI) versus conventional intermittent dosing (ID) of CZA in critically ill ICU patients with severe infections caused by K. pneumoniae OXA-48 or P. aeruginosa.

This single-centre, randomized, open-label trial will be conducted at a tertiary care hospital within the University Hospital Centre in Zagreb, Croatia, with a 1:1 allocation ratio. One hundred forty critically ill ICU patients requiring CZA treatment will be randomized to receive either ID (2 g/0.5 g every 8 hours over 2 hours) or an equivalent dose in CI (6 g/1.5 g continuously over 24 hours).

The primary outcome is the microbiological success rate. Secondary outcomes include clinical success rate, time to symptom improvement, length of ICU and hospital stay, 28-day all-cause mortality, pathogen recurrence rate, time to weaning from mechanical ventilation, cumulative vasoactive-inotropic score, adverse events, and the ratio of ceftazidime plasma concentration to the pathogen's minimum inhibitory concentration (C/MIC).

This trial seeks to provide evidence on the optimal administration strategy for CZA in critically ill ICU patients with severe infections due to MDR G- pathogens.

Conditions: Severe Infection
Being tested: Continuos ceftazidime/avibactam infusion, Intermitent dosing as per SMPC
Keywords: ceftazidime/avibactam, continuous infusion, critically ill, ICU, Klebsiella pneumoniae OXA-48, Pseudomonas aeruginosa
Medical subject headings: Infections, Critical Illness, Pseudomonas Infections

What participants receive

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

Continuos ceftazidime/avibactam infusionDrug
Continuous infusion will include a loading dose of 2 g/0.5 g administered over 2 hours, followed by continuous infusion of 6 g/1.5 g over 24 hours, equivalent to 0.25 g of ceftazidime per hour. The drug reconstitution and dilution process are shown in Figure 2. The final volume of solution of CZA will be 50 mL, which gives concentration of ceftazidime of 40 mg/mL, with 4:1 concentration ratio for avibactam (10 mg/mL). The solution will be administered via an infusion syringe, with an infusion rate of 6.25 mL/h. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula
Intermitent dosing as per SMPCDrug
Intermittent dosing, as outlined in the SmPC, consists of 2 g/0.5 g administered by prolonged infusion over 2 hours every 8 hours. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula.

Study groups in NCT06811727
Study group	Role	What they receive
Continuos ceftazidime/avibactam infusion	Experimental	Continuous infusion will include a loading dose of 2 g/0.5 g administered over 2 hours, followed by continuous infusion of 6 g/1.5 g over 24 hours, equivalent to 0.25 g of ceftazidime per hour. The drug reconstitution and dilution process are shown in Figure 2. The final volume of a solution of CZA will be 50 mL, which gives the concentration of ceftazidime 40 mg/mL, with a 4:1 concentration ratio for avibactam (10 mg/mL). The solution will be administered via an infusion syringe with an infusion rate of 6.25 mL/h. Dose adjustments will be applied according to renal function, calculated using the Cockroft-Gault formula Receives: Drug: Continuos ceftazidime/avibactam infusion
Intermitent dosing as per SMPC	Active comparator	Intermittent dosing, as outlined in the SmPC, consists of 2 g/0.5 g administered by prolonged infusion over 2 hours every 8 hours. Dose adjustments will be applied according to renal function, calculated using the Cockroft-Gault formula. Receives: Drug: Intermitent dosing as per SMPC

What is being measured

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

microbiological success rate
The aim of this study is to investigate efficacy of continuous infusion of ceftazidime/avibactam compared to conventional intermittent dosing, in treating critically ill ICU patients with severe infections caused by Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa. The primary outcome of the study is microbiological success rate, defined by proportion of patients in whom the causative pathogen is absent from specimen at the site of infection.
Measured: 28 days

Secondary outcomes (8)

clinical success rate
The clinical success rate is the proportion of patients who achieve clinical cure or clinical improvement evaluated at the end of therapy.
Clinical cure is the complete resolution of all signs and symptoms, with no evidence of ongoing infection. Clinical improvement is a significant reduction in infection-related signs and symptoms such that the patient demonstrates considerable progress towards recovery.
Measured: 28 day
time to symptoms improvement
Patients who achieve clinical cure or clinical improvement
Measured: 28 day
length of ICU stay
Length of ICU stay is defined as the total number of days from the day of the first CZA administration (study day on 0) until either:
Discharge from the ICU (if the patient is transferred out of the ICU before day 28) Day 28 (for patients who remain in the ICU beyond this time)
Measured: 28 day
length of hospital stay
Length of hospital stay is defined as the total number of days from the day of the first CZA administration (study day on 0) until either:
Discharge from the hospital (if the patient is discharged before day 28) Day 28 (for patients who remain hospitalized beyond this time)
Measured: 28 day
all-cause 28-day mortality after ceftazidime/avibactam initiation
All-cause 28-day mortality is defined as death at any point up to and including study day 28. The 28-day mortality rate will be calculated as the number of deaths divided by the total number of patients in the group, expressed as a percentage.
Measured: 28 day
pathogen recurrence rate on day 28
The pathogen recurrence rate on day 28 is defined as the proportion of patients who have a recurrence of the initial causative pathogen from clinical or surveillance microbiological samples taken by study day 28 after completion of CZA therapy.
Measured: 28 day
time to weaning from mechanical ventilation
time in hours from the start of the trial to the end of mechanical ventilation
Measured: 28 days
cumulative vasoactive-inotropic score (VIS)
The vasoactive-inotropic score is a quantitative measure that evaluates the cumulative effect of vasoactive and inotropic medications. It is calculated using the following formula:
VIS = dobutamine dose (μg/kg/min) + adrenaline dose (μg/kg/min) x 100 + noradrenaline dose (μg/kg/min) x 100 + vasopressin dose (IU/kg/min) x 10 + angiotensin II dose (ng/kg/min) x 10000 24-hour VIS quantifies the overall cardiovascular support required over 24 hours. The average daily VIS score will be calculated using the following formula: Daily VIS=∑ (VIS for each interval × interval duration (hours)/24 An interval is defined as the period where drug doses remain constant.
Measured: 28 day

Timeline

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

1 Aug 20251 Aug 2029

First posted6 Feb 2025
Study start1 Aug 2025
Primary completion1 May 2029 (estimated)
Study completion1 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Severe InfectionStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06811727
Sponsor's protocol ID: ZAVICONT01
Acronym: ZAVICONT
Status last verified: Oct 2026
First submitted: 28 Jan 2025
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Servais H, Tulkens PM. Stability and compatibility of ceftazidime administered by continuous infusion to intensive care patients. Antimicrob Agents Chemother. 2001 Sep;45(9):2643-7. doi: 10.1128/AAC.45.9.2643-2647.2001.
PubMed 11502544
Gatti M, Pea F. Continuous versus intermittent infusion of antibiotics in Gram-negative multidrug-resistant infections. Curr Opin Infect Dis. 2021 Dec 1;34(6):737-747. doi: 10.1097/QCO.0000000000000755.
PubMed 34261906
Adembri C, Novelli A, Nobili S. Some Suggestions from PK/PD Principles to Contain Resistance in the Clinical Setting-Focus on ICU Patients and Gram-Negative Strains. Antibiotics (Basel). 2020 Oct 6;9(10):676. doi: 10.3390/antibiotics9100676.
PubMed 33036190
Lorente L, Jimenez A, Palmero S, Jimenez JJ, Iribarren JL, Santana M, Martin MM, Mora ML. Comparison of clinical cure rates in adults with ventilator-associated pneumonia treated with intravenous ceftazidime administered by continuous or intermittent infusion: a retrospective, nonrandomized, open-label, historical chart review. Clin Ther. 2007 Nov;29(11):2433-9. doi: 10.1016/j.clinthera.2007.11.003.
PubMed 18158083
Gomez CM, Cordingly JJ, Palazzo MG. Altered pharmacokinetics of ceftazidime in critically ill patients. Antimicrob Agents Chemother. 1999 Jul;43(7):1798-802. doi: 10.1128/AAC.43.7.1798.
PubMed 10390248
Muller AE, Punt N, Mouton JW. Optimal exposures of ceftazidime predict the probability of microbiological and clinical outcome in the treatment of nosocomial pneumonia. J Antimicrob Chemother. 2013 Apr;68(4):900-6. doi: 10.1093/jac/dks468. Epub 2012 Nov 28.
PubMed 23190766
Ali A, Imran M, Sial S, Khan A. Effective antibiotic dosing in the presence of resistant strains. PLoS One. 2022 Oct 10;17(10):e0275762. doi: 10.1371/journal.pone.0275762. eCollection 2022.
PubMed 36215219
Ghazi IM, El Nekidy WS. Editorial: Advances in antimicrobial therapy and combating resistance. Front Pharmacol. 2023 Mar 16;14:1170289. doi: 10.3389/fphar.2023.1170289. eCollection 2023. No abstract available.
PubMed 37007043
Batchelder JI, Hare PJ, Mok WWK. Resistance-resistant antibacterial treatment strategies. Front Antibiot. 2023;2:1093156. doi: 10.3389/frabi.2023.1093156. Epub 2023 Jan 30.
PubMed 36845830
Poole K. Pseudomonas aeruginosa: resistance to the max. Front Microbiol. 2011 Apr 5;2:65. doi: 10.3389/fmicb.2011.00065. eCollection 2011.
PubMed 21747788
Bonomo RA, Burd EM, Conly J, Limbago BM, Poirel L, Segre JA, Westblade LF. Carbapenemase-Producing Organisms: A Global Scourge. Clin Infect Dis. 2018 Apr 3;66(8):1290-1297. doi: 10.1093/cid/cix893.
PubMed 29165604
Chen T, Xu H, Chen Y, Ji J, Ying C, Liu Z, Xu H, Zhou K, Xiao Y, Shen P. Identification and Characterization of OXA-232-Producing Sequence Type 231 Multidrug Resistant Klebsiella pneumoniae Strains Causing Bloodstream Infections in China. Microbiol Spectr. 2023 Apr 13;11(2):e0260722. doi: 10.1128/spectrum.02607-22. Epub 2023 Mar 22.
PubMed 36946763
Garcia-Gonzalez N, Fuster B, Tormo N, Salvador C, Gimeno C, Gonzalez-Candelas F. Genomic analysis of the initial dissemination of carbapenem-resistant Klebsiella pneumoniae clones in a tertiary hospital. Microb Genom. 2023 Jun;9(6):mgen001032. doi: 10.1099/mgen.0.001032.
PubMed 37272914
Ceron S, Salem-Bango Z, Contreras DA, Ranson EL, Yang S. Clinical and Genomic Characterization of Carbapenem-Resistant Klebsiella pneumoniae with Concurrent Production of NDM and OXA-48-like Carbapenemases in Southern California, 2016-2022. Microorganisms. 2023 Jun 30;11(7):1717. doi: 10.3390/microorganisms11071717.
PubMed 37512889

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients With Klebsiella Pneumoniae OXA-48 or Pseudomonas Aeruginosa Infections: A Single-centre Randomized Open-label Trial (ZAVICONT)
ClinicalTrials.gov ID: NCT06811727
Acronym / sponsor ID: ZAVICONT / ZAVICONT01
Conditions: Severe Infection
Keywords: ceftazidime/avibactam, continuous infusion, critically ill, ICU, Klebsiella pneumoniae OXA-48, Pseudomonas aeruginosa
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Ivan Šitum, MDUniversity, hospital or other
Collaborators: UHC Zagreb, Zagreb, Croatia, Daniel Lovrić, Mirna Momčilović
Study start: 1 Aug 2025 (actual)
Primary completion: 1 May 2029 (estimated)
Study completion: 1 Aug 2029 (estimated)
First posted: 6 Feb 2025 (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 trial seeks to provide evidence on the optimal administration strategy for CZA in critically ill ICU patients with severe infections due to MDR G- pathogens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Continuos ceftazidime/avibactam infusion	Experimental	Drug: Continuos ceftazidime/avibactam infusionContinuous infusion will include a loading dose of 2 g/0.5 g administered over 2 hours, followed by continuous infusion of 6 g/1.5 g over 24 hours, equivalent to 0.25 g of ceftazidime per hour. The drug reconstitution and dilution process are shown in Figure 2. The final volume of a solution of CZA will be 50 mL, which gives the concentration of ceftazidime 40 mg/mL, with a 4:1 concentration ratio for avibactam (10 mg/mL). The solution will be administered via an infusion syringe with an infusion rate of 6.25 mL/h. Dose adjustments will be applied according to renal function, calculated using the Cockroft-Gault formula
Intermitent dosing as per SMPC	Active comparator	Drug: Intermitent dosing as per SMPCIntermittent dosing, as outlined in the SmPC, consists of 2 g/0.5 g administered by prolonged infusion over 2 hours every 8 hours. Dose adjustments will be applied according to renal function, calculated using the Cockroft-Gault formula.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

General
Disease-specific

Key exclusion criteria (14 listed)

General
Laboratory values
1. Severe neutropenia before or during ceftazidime/avibactam administration.
Medical conditions

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
Continuos ceftazidime/avibactam infusionContinuous infusion will include a loading dose of 2 g/0.5 g administered over 2 hours, followed by continuous infusion of 6 g/1.5 g over 24 hours, equivalent to 0.25 g of ceftazidime per hour. The drug reconstitution and dilution process are shown in Figure 2. The final volume of solution of CZA will be 50 mL, which gives concentration of ceftazidime of 40 mg/mL, with 4:1 concentration ratio for avibactam (10 mg/mL). The solution will be administered via an infusion syringe, with an infusion rate of 6.25 mL/h. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula	Drug	Continuos ceftazidime/avibactam infusion
Intermitent dosing as per SMPCIntermittent dosing, as outlined in the SmPC, consists of 2 g/0.5 g administered by prolonged infusion over 2 hours every 8 hours. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula.	Drug	Intermitent dosing as per SMPC

Primary outcome

microbiological success rate
Time frame: 28 days
The aim of this study is to investigate efficacy of continuous infusion of ceftazidime/avibactam compared to conventional intermittent dosing, in treating critically ill ICU patients with severe infections caused by Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa. The primary outcome of the study is microbiological success rate, defined by proportion of patients in whom the causative pathogen is absent from specimen at the site of infection.

8 secondary outcomes

clinical success rate
Time frame: 28 day
time to symptoms improvement
Time frame: 28 day
length of ICU stay
Time frame: 28 day
length of hospital stay
Time frame: 28 day
all-cause 28-day mortality after ceftazidime/avibactam initiation
Time frame: 28 day
pathogen recurrence rate on day 28
Time frame: 28 day
time to weaning from mechanical ventilation
Time frame: 28 days
cumulative vasoactive-inotropic score (VIS)
Time frame: 28 day

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 2 Nov 2026.
Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Background: PubMed 11502544Servais H, Tulkens PM. Stability and compatibility of ceftazidime administered by continuous infusion to intensive care patients. Antimicrob Agents Chemother. 2001 Sep;45(9):2643-7. doi: 10.1128/AAC.45.9.2643-2647.2001.
Background: PubMed 34261906Gatti M, Pea F. Continuous versus intermittent infusion of antibiotics in Gram-negative multidrug-resistant infections. Curr Opin Infect Dis. 2021 Dec 1;34(6):737-747. doi: 10.1097/QCO.0000000000000755.
Background: PubMed 33036190Adembri C, Novelli A, Nobili S. Some Suggestions from PK/PD Principles to Contain Resistance in the Clinical Setting-Focus on ICU Patients and Gram-Negative Strains. Antibiotics (Basel). 2020 Oct 6;9(10):676. doi: 10.3390/antibiotics9100676.
Background: PubMed 18158083Lorente L, Jimenez A, Palmero S, Jimenez JJ, Iribarren JL, Santana M, Martin MM, Mora ML. Comparison of clinical cure rates in adults with ventilator-associated pneumonia treated with intravenous ceftazidime administered by continuous or intermittent infusion: a retrospective, nonrandomized, open-label, historical chart review. Clin Ther. 2007 Nov;29(11):2433-9. doi: 10.1016/j.clinthera.2007.11.003.
Background: PubMed 10390248Gomez CM, Cordingly JJ, Palazzo MG. Altered pharmacokinetics of ceftazidime in critically ill patients. Antimicrob Agents Chemother. 1999 Jul;43(7):1798-802. doi: 10.1128/AAC.43.7.1798.
Background: PubMed 23190766Muller AE, Punt N, Mouton JW. Optimal exposures of ceftazidime predict the probability of microbiological and clinical outcome in the treatment of nosocomial pneumonia. J Antimicrob Chemother. 2013 Apr;68(4):900-6. doi: 10.1093/jac/dks468. Epub 2012 Nov 28.
Background: PubMed 36215219Ali A, Imran M, Sial S, Khan A. Effective antibiotic dosing in the presence of resistant strains. PLoS One. 2022 Oct 10;17(10):e0275762. doi: 10.1371/journal.pone.0275762. eCollection 2022.
Background: PubMed 37007043Ghazi IM, El Nekidy WS. Editorial: Advances in antimicrobial therapy and combating resistance. Front Pharmacol. 2023 Mar 16;14:1170289. doi: 10.3389/fphar.2023.1170289. eCollection 2023. No abstract available.
Background: PubMed 36845830Batchelder JI, Hare PJ, Mok WWK. Resistance-resistant antibacterial treatment strategies. Front Antibiot. 2023;2:1093156. doi: 10.3389/frabi.2023.1093156. Epub 2023 Jan 30.
Background: PubMed 21747788Poole K. Pseudomonas aeruginosa: resistance to the max. Front Microbiol. 2011 Apr 5;2:65. doi: 10.3389/fmicb.2011.00065. eCollection 2011.
Background: PubMed 29165604Bonomo RA, Burd EM, Conly J, Limbago BM, Poirel L, Segre JA, Westblade LF. Carbapenemase-Producing Organisms: A Global Scourge. Clin Infect Dis. 2018 Apr 3;66(8):1290-1297. doi: 10.1093/cid/cix893.
Individual participant dataSharing planned: No

Related trials for Severe Infection

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis

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.

Ivan Šitum, MD contact

0915143620

ivsitum@gmail.com

Daniel Lovrić, MD, PhD contact

385914488350

daniel@lovric.net

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Continuos ceftazidime/avibactam infusion and Intermitent dosing as per SMPC in people with Severe Infection, run by Ivan Šitum, MD at 1 site in Croatia.

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 14 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Croatia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ivan Šitum, MD (0915143620, ivsitum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

microbiological success rate (time frame: 28 days). 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 NCT06811727, which also lists 17 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 2 Nov 2026.