BacteremiaPhase 3ASTARTÉNCT04478721
Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
A Phase 3 study testing Temocillin and Meropenem in people with Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
Trial summary
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Temocillin and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 29 sitesSpain
- Study dates
- 15 Dec 2020to 26 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
- Patients with polymicrobial bacteremia caused by more than one Enterobacteriaceae species may also be included, provided at least one of them is resistant to third-generation cephalosporins, and both are susceptible to meropenem and temocillin.
- Duration of intravenous treatment is planned to be at least 4 days from randomization, or 3 days if the empirical treatment prior to randomization was active.
- The patient signed informed consent form.
- Potentially fertile patients must have a negative pregnancy test.
Who cannot join
- <18 years
- Pregnancy
- Breastfeeding
- Terminal condition, with life expectancy of less than 30 days, or palliative care , such that no actions will be taken to control the source of infection if necessary. Patients receiving palliative care with a life expectancy greater than 30 days may be included if source control is not necessary or, if necessary, will be carried out.
- Allergy to betalactams
- Polymicrobial bacteraemia (except when the other microorganism is considered a contaminant, (e.g. coagulase-negative staphylococci or diphtheroids in a single blood culture, or in cases where more than one Enterobacteriaceae species is isolated, provided that at least one isolate is resistant to third-generation cephalosporins and both are susceptible to meropenem and temocillin).
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- Infections typically needing prolonged >14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis. Patients who initially do not have a confirmed diagnosis of these infections may be included; if the diagnosis is made subsequently, the patient may be kept in the trial at the discretion of the investigator, establishing the duration of treatment that he considers necessary.
- Active empirical treatment> 96 hours after initial blood culture extraction
- Delay in inclusion> 48 h
- Recruited in another clinical trial with active treatment
- Peritoneal dialysis or continuous hemofiltration
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Complejo Hospitalario Universitario La Coruña
A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Torrecárdenas
Almería, 04009
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital del Mar
Barcelona, 08003
Hospital Sant Pau
Barcelona, 08041
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario Clínico San Cecilio
Granada, 18016
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Complejo Hospitalario San Millán-San Pedro De La Rioja
Logroño, La Rioja, 26560
Hospital Universitario Locus Augusti, Lugo
Lugo, 27003
Hospital Universitario de la Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Regional de Málaga
Málaga, 29010
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitari Son Espases
Palma, 07120
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, 11510
Hospital ParcTaulí
Sabadell, Barcelona, 08208
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, 08221
Complejo Hospitalario Universitario de Vigo
Vigo, 36313
About this study
Official title: Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Read the detailed description
The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
- Conditions
- Bacteremia
- Being tested
- Temocillin, Meropenem
- Keywords
- Bacteraemia, Enterobacteriaceae, Temocillin, Third-generation cephalosporin-resistant Enterobacteriaceae.
- Medical subject headings
- Bacteremia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemocillinDrug
The intervention of experimental arm will be Intravenous administration of temocillin.
MeropenemDrug
The intervention of comparator arm will be intravenous administration of meropenem.
| Study group | Role | What they receive |
|---|---|---|
| Temocillin | Experimental | Patients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin. Receives: Drug: Temocillin |
| Meropenem | Active comparator | Patients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem. Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a "success" at the test of cure (TOC)
A success at the test of cure is the resolution of infection symptoms
Measured: Up to 7-10 days after the last day of antibiotic therapy
Survival at day 28
Number of patients who are alive
Measured: At day 28.
Number of patients who do not need to stop or change the assigned drug
Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection.
Participants who stop or change the assigned drug will not meet the primary outcome.
Measured: Up to 7-14 days after the last day of antibiotic therapy
Number of patients who do not need to prolong therapy beyond 14 days
Assigned treatment to be administered for less than 14 days
Measured: Up to 7-14 days after the last day of antibiotic therapy
Not recurrence until day 28
Recurrence is reappearance of symptoms with positive blood culture for the same microorganism.
Participants with recurrence will not meet the primary outcome.
Measured: At day 28.
Secondary outcomes (10)
28-day mortality
Number of patients dead up to day 28.
Measured: Up to day 28.
Length of hospital stay (days)
Number of days patients has been in-hospital
Measured: Through study completion, an average of 28 days
Length of intravenous therapy (days)
Number of days patients has been under intravenous antibiotic treatment
Measured: From day 1 of intravenous antibiotic treatment administration to last intravenous administration, average 14 days
Length of total administration of therapy (days)
Number of days patients has been under intravenous or oral antibiotic treatment
Measured: From day 1 of intravenous or oral antibiotic treatment administration to last intravenous or oral administration, average 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to day 28
Number of subjects with resistance development during therapy
Resistance development will be measured in a positive blood culture
Measured: Up to day 28
Recurrence rate
Percentage of subjects with recurrence
Measured: Up to day 28.
Changes in Sequential Organ failure (SOFA) score
Sequential Organ failure (SOFA) score changes
Measured: At days 1, 3, end of treatment (days 7-14) and visit 4
Changes in Barthel Index for Activities of Daily Living (ADL) for patients older than 70 years old
Barthel Index for Activities of Daily Living (ADL) score changes; score from 0, completely dependent patient to 100, completely independent for activities of daily living
Measured: At days 1, 3, end of treatment (days 7-14) and visit 4
Number of subjects with development of superimposed infections.
Development of superimposed infections will be measured in a positive culture
Measured: Up to day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Dec 2020
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies 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
- Randomized 1.1 to temocillin: meropenem
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Jesús Rodriguez Baño, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478721
- Sponsor's protocol ID
- ASTARTÉ
- Other IDs
- 2020-000064-39
- Acronym
- ASTARTÉ
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Planning for the study will be shared with potential sites pertaining to Spanish Network for Research in Infectious Disease (REIPI)for participation. IPD is not foreseen out of this groups due to the specific characteristics of patients and sites to be candidates for study participation.
Publications
Dezza FC, Pulido LB, Borreguero IB, Perez FD, Jimenez VP, de la Rosa Riestra S, Bravo-Ferrer JM, Palacios-Baena ZR, Zuniga MAL, Cobo F, Gomez-Junyent J, Horcajada JP, Merino E, Parra M, Lopez-Contreras J, Rivera A, Regueiro DS, Garcia MP, Cardenas SL, Sanchez MCG, Camacho IP, Ramos SMM, Jimenez EL, Garcia AIA, Perez-Rodriguez MT, Sousa A, Ruiz MS, de Las Revillas Almajano FA, Perez LG, Agirre JG, Cano A, Martinez-Marcos FJ, Pais MJG, Sanchez RE, de la Villa S, Ara JRY, Esteban-Moreno MA, Ruiz-Sancho A, Aragon MP, Fernandez JA, Blandino AMB, Vilchez-Rueda HH, Alvarez-Marin R, Palacios AR, Vazquez EG, Alvarez EN, Rosso-Fernandez C, Gutierrez-Gutierrez B, Pascual A, Lopez-Cerero L, Rodriguez-Bano J; ASTARTE-GEIRAS study group. Temocillin versus carbapenems for bacteraemia due to third-generation cephalosporin-resistant Enterobacterales in Spain (ASTARTE): a multicentre, phase 3, open-label, non-inferiority, randomised clinical trial. Lancet. 2026 Aug 1;408(10553):430-439. doi: 10.1016/S0140-6736(26)00760-9. Epub 2026 Jul 9.
PubMed 42425122Marin-Candon A, Rosso-Fernandez CM, Bustos de Godoy N, Lopez-Cerero L, Gutierrez-Gutierrez B, Lopez-Cortes LE, Barrera Pulido L, Borreguero Borreguero I, Leon MJ, Merino V, Camean-Fernandez M, Retamar P, Salamanca E, Pascual A, Rodriguez-Bano J; ASTARTE Study Group. Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTE): protocol for a randomised, pragmatic trial. BMJ Open. 2021 Sep 27;11(9):e049481. doi: 10.1136/bmjopen-2021-049481.
PubMed 34580096
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins
- ClinicalTrials.gov ID
- NCT04478721
- Acronym / sponsor ID
- ASTARTÉ / ASTARTÉ
- Conditions
- Bacteremia
- Keywords
- Bacteraemia, Enterobacteriaceae, Temocillin, Third-generation cephalosporin-resistant Enterobacteriaceae.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases, Spanish Clinical Research Network - SCReN
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 21 Jul 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.
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Detailed description
The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1.1 to temocillin: meropenem
| Arm | Type | Receives |
|---|---|---|
| Temocillin | Experimental | Drug: TemocillinPatients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin. |
| Meropenem | Active comparator | Drug: MeropenemPatients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
- Patients with polymicrobial bacteremia caused by more than one Enterobacteriaceae species may also be included, provided at least one of them is resistant to third-generation cephalosporins, and both are susceptible to meropenem and temocillin.
- Duration of intravenous treatment is planned to be at least 4 days from randomization, or 3 days if the empirical treatment prior to randomization was active.
- The patient signed informed consent form.
- Potentially fertile patients must have a negative pregnancy test.
Key exclusion criteria (11 listed)
- <18 years
- Pregnancy
- Breastfeeding
- Terminal condition, with life expectancy of less than 30 days, or palliative care , such that no actions will be taken to control the source of infection if necessary. Patients receiving palliative care with a life expectancy greater than 30 days may be included if source control is not necessary or, if necessary, will be carried out.
- Allergy to betalactams
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 |
|---|---|---|
| TemocillinThe intervention of experimental arm will be Intravenous administration of temocillin. | Drug | Temocillin |
| MeropenemThe intervention of comparator arm will be intravenous administration of meropenem. | Drug | Meropenem |
Primary outcome
Number of participants with a "success" at the test of cure (TOC)
Time frame: Up to 7-10 days after the last day of antibiotic therapy
A success at the test of cure is the resolution of infection symptoms
Survival at day 28
Time frame: At day 28.
Number of patients who are alive
Number of patients who do not need to stop or change the assigned drug
Time frame: Up to 7-14 days after the last day of antibiotic therapy
Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection. Participants who stop or change the assigned drug will not meet the primary outcome.
Number of patients who do not need to prolong therapy beyond 14 days
Time frame: Up to 7-14 days after the last day of antibiotic therapy
Assigned treatment to be administered for less than 14 days
Not recurrence until day 28
Time frame: At day 28.
Recurrence is reappearance of symptoms with positive blood culture for the same microorganism. Participants with recurrence will not meet the primary outcome.
10 secondary outcomes
28-day mortality
Time frame: Up to day 28.
Length of hospital stay (days)
Time frame: Through study completion, an average of 28 days
Length of intravenous therapy (days)
Time frame: From day 1 of intravenous antibiotic treatment administration to last intravenous administration, average 14 days
Length of total administration of therapy (days)
Time frame: From day 1 of intravenous or oral antibiotic treatment administration to last intravenous or oral administration, average 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to day 28
Number of subjects with resistance development during therapy
Time frame: Up to day 28
Recurrence rate
Time frame: Up to day 28.
Changes in Sequential Organ failure (SOFA) score
Time frame: At days 1, 3, end of treatment (days 7-14) and visit 4
Changes in Barthel Index for Activities of Daily Living (ADL) for patients older than 70 years old
Time frame: At days 1, 3, end of treatment (days 7-14) and visit 4
Number of subjects with development of superimposed infections.
Time frame: Up to day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 42425122Dezza FC, Pulido LB, Borreguero IB, Perez FD, Jimenez VP, de la Rosa Riestra S, Bravo-Ferrer JM, Palacios-Baena ZR, Zuniga MAL, Cobo F, Gomez-Junyent J, Horcajada JP, Merino E, Parra M, Lopez-Contreras J, Rivera A, Regueiro DS, Garcia MP, Cardenas SL, Sanchez MCG, Camacho IP, Ramos SMM, Jimenez EL, Garcia AIA, Perez-Rodriguez MT, Sousa A, Ruiz MS, de Las Revillas Almajano FA, Perez LG, Agirre JG, Cano A, Martinez-Marcos FJ, Pais MJG, Sanchez RE, de la Villa S, Ara JRY, Esteban-Moreno MA, Ruiz-Sancho A, Aragon MP, Fernandez JA, Blandino AMB, Vilchez-Rueda HH, Alvarez-Marin R, Palacios AR, Vazquez EG, Alvarez EN, Rosso-Fernandez C, Gutierrez-Gutierrez B, Pascual A, Lopez-Cerero L, Rodriguez-Bano J; ASTARTE-GEIRAS study group. Temocillin versus carbapenems for bacteraemia due to third-generation cephalosporin-resistant Enterobacterales in Spain (ASTARTE): a multicentre, phase 3, open-label, non-inferiority, randomised clinical trial. Lancet. 2026 Aug 1;408(10553):430-439. doi: 10.1016/S0140-6736(26)00760-9. Epub 2026 Jul 9.
- Derived from this study: PubMed 34580096Marin-Candon A, Rosso-Fernandez CM, Bustos de Godoy N, Lopez-Cerero L, Gutierrez-Gutierrez B, Lopez-Cortes LE, Barrera Pulido L, Borreguero Borreguero I, Leon MJ, Merino V, Camean-Fernandez M, Retamar P, Salamanca E, Pascual A, Rodriguez-Bano J; ASTARTE Study Group. Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTE): protocol for a randomised, pragmatic trial. BMJ Open. 2021 Sep 27;11(9):e049481. doi: 10.1136/bmjopen-2021-049481.
- Individual participant dataSharing planned: Yes. Planning for the study will be shared with potential sites pertaining to Spanish Network for Research in Infectious Disease (REIPI)for participation. IPD is not foreseen out of this groups due to the specific characteristics of patients and sites to be candidates for study participation.
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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.
Jesús Rodriguez Baño principal investigator
Hospital Universitario Virgen Macarena
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temocillin and Meropenem in people with Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a "success" at the test of cure (TOC) (time frame: Up to 7-10 days after the last day of antibiotic therapy). The study lists 5 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 NCT04478721, which also lists 2 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 23 Jan 2026.