Febrile NeutropeniaPhase 4SHORTNCT02149329
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO
A Phase 4 study testing Discontinuation of imipenem-cilastatin or meropenem in people with Febrile Neutropenia and Hematological Malignancy, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia, Hematological Malignancy
- What is being tested?
- Discontinuation of imipenem-cilastatin or meropenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 2014to 5 Aug 2019
- Phase
- Phase 4
- 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
- Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
- High-risk neutropenia (Absolute neutrophil count (ANC) <0.5x109/L which is expected to last longer than 7 days);
- Fever (One single measured tympanic membrane temperature of >38.5°C or a temperature of >38.0°C during 2 subsequent measurements separated by at least 2 hours);
- Age 18 years or older;
- Written informed consent.
Who cannot join
- Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
- Corticosteroid use ≥10 mg per day prednisolone or equivalent for more than 3 consecutive day during the previous 7 days.
- Clinically or microbiologically documented infection.
- Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
- Previous enrollment in this study during the same episode of neutropenia.
- Any critical illness for which Intensive Care Unit treatment is required.
- Legal incompetency
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VU university medical center
Amsterdam, 1081 HV
HAGA ziekenhuis
The Hague
About this study
Official title: Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With Fever of Unknown Origin: a Randomized Multicenter Non-inferiority Trial.
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
Read the detailed description
Episodes of fever are very common in patients undergoing intensive chemotherapy treatment for malignant hematological disease. More than 80% of patients experience one or more episodes of fever after their first cycle of chemotherapy. Only 20-30% of these patients have a clinically documented focus and mostly include infections of skin, intestinal tract and lung, while at most 10-25% of these patients have microbiologically proven bacteremia during these episodes. Patients with malignant hematological diseases and intensive chemotherapy induced neutropenia are extremely prone to overwhelming bacterial infections. Therefore, empirical antibiotic treatment is initiated at the first occurrence of fever, even if no apparent cause for the fever is evident. Most protocols advice treatment with very broad-spectrum antibiotics, mostly anti-pseudomonal carbapenems or fourth generation anti-pseudomonal cephalosporins.
Prolonged continuation of treatment may induce bacterial resistance. In view of the possible emergence of bacterial resistance due to prolonged antibiotic administration, continuation until recovery of neutropenia is suboptimal because it is costly because of longer hospital admissions, higher antibiotics costs and more possible adverse reactions.
Recent observational data (Slobbe et al) has showed that in adult hematological patients with febrile neutropenia, discontinuation of empiric antibacterial therapy after three days can be safe if no infectious etiology can be found, even in cases with persistent fever. However no RCT has hitherto been performed to support this observational data.
This study compares the safety (non-inferiority) of short treatment (72 hours) versus extended treatment (at least 9 days) with an anti-pseudomonal carbapenem for hematology patients with unexplained high risk febrile neutropenia. We hypothesize that a more restrictive use of broad-spectrum antibiotic use of three days in unexplained fever in neutropenic hematology patients is non-inferior to the present extended use during at least 9 days which would lead to a more restrictive use of antibiotics and less multiresistant strains of bacteria, costs and hospitalization length in the future.
- Conditions
- Febrile Neutropenia, Hematological Malignancy
- Being tested
- Discontinuation of imipenem-cilastatin or meropenem
- Keywords
- fever, neutropenia, febrile neutropenia, carbapenem, imipenem, meropenem, antibiotic stewardship, hematology, oncology
- Medical subject headings
- Febrile Neutropenia, Hematologic Neoplasms, Fever, Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of imipenem-cilastatin or meropenemDrug
Also called tienam (imipenem-cilastatin)
Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.
| Study group | Role | What they receive |
|---|---|---|
| Short treatment | Experimental | Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever. Receives: Drug: Discontinuation of imipenem-cilastatin or meropenem |
| Extended treatment | No intervention | Extended treatment with imipenem-cilastatin or meropenem for at least 6 more days. The treatment with a carbapenem will be continued until patients have been treated for at least 9x24 hours and have been afebrile (tympanic membrane temperature <38.0°C) for at least five consecutive days or until resolution of neutropenia (ANC > 0,5 x10^9/L), whichever comes first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with failed treatment
Treatment failure is defined as the occurrence of one of the following events after 3x24 hours and before 9x24hours after treatment initiation with a carbapenem:
-A clinically or microbiologically documented carbapenem-sensitive infection; treatment.
Recurrence of fever after previous defervescence (tympanic temperature <38.0 °C during 24 hours) which is not attributable to administration of a blood product or to a drug reaction.
- In case of clinical doubt whether the fever is of infectious etiology, the recurrence of fever will be considered as failure.
Measured: Between randomization (at 3x24 hours) and before 9x24hours after treatment initiation)
Death/ARDS or Septic shock
The occurrence of death, ARDS/respiratory insufficiency, septic shock (systolic blood pressure <90 mmHg and oliguria <500 mL/day) due to any cause.
Measured: From randomization until the end of neutropenia (neutrophil count >=0.5x10e9/L) up to 6 months after randomization.
Secondary outcomes (14)
All-cause mortality.
Measured: 1. From 3x24hours of treatment until the end of neutropenia. 2. Within 30 days after the end of neutropenia
Infection-related mortality.
Measured: 1. From 3x24hours of treatment until the end of neutropenia. 2.Within 30 days after recovery of neutropenia
The length of hospitalization in days.
Measured: From admission until discharge, with an estimated average of 4 weeks
Treatment strategy failure
Treatment strategy failure is defined as occurrence of any of the following events after 3x24hours of treatment with a carbapenem and until the end of the neutropenic episode:
- Any clinically or microbiologically documented infection.
- The recurrence of fever after previous defervescence during neutropenia.
- Death, septic shock or ARDS/respiratory failure due to any cause
- Adverse drug-related events due to a carbapenem requiring (temporary) interruption of treatment, including but not exclusively: liver and kidney dysfunction, convulsion and allergic reactions.
- Unexpected re-admission within 30 days after discharge other than for planned chemotherapy or other elective treatment.
- Antibiotic or antifungal treatment within 30days after discharge other than standard antibiotic prophylaxis.
Measured: after 3x24hours of treatment with a carbapenem and until the end of the neutropenic episode
The total number of febrile episodes during neutropenia.
Measured: From the start of neutropenia (ANC<0.5x10^9) until the end of neutropenia, an expected average of 21 days
Time to defervescence
Fever is defined as one single measured tympanic membrane temperature of >38.5°C or a temperature of >38.0°C during 2 subsequent measurements separated by at least 2 hours.
Defervescence is defined as three times a tympanic membrane temperature <37.5 °C with a minimal measurement interval of at least 8 hours
Measured: Onset of fever until defervenscence, an expected average of 5 days.
Incidence and prevalence of Clostridium difficile infection
Measured: Onset of fever until 30 days after the end of neutropenia.
Candida spp. colonization in (surveillance) cultures
Measured: From onset of fever until 30 days after the end of neutropenia.
Cost of antimicrobial therapy per admission
Measured: From admission until discharge, with an estimated average of 4 weeks
The percentage of patients with a MASCC-score≥21 and treatment failure (defined as in primary endpoint)
Measured: From the onset of fever until the end of the neutropenic episode, with an estimated average of 21 days.
The percentage of patients with mucositis and positive blood cultures or short treatment failure.
Measured: From onset of fever until 30 days after end of neutropenia.
Bacterial resistance in blood cultures and surveillance cultures (including minimal inhibitory concentrations (MIC)).
Measured: All previous cultures and cultures performed until 30 days after the end of neutropenia.
The incidence and prevalence of fungal, viral, or carbapenem-resistant (inherent/acquired) infections until the end of neutropenia
Measured: om the onset of fever until the end of the neutropenic episode, with an estimated average of 21 days.
Late treatment failure
Defined as primary endpoint.
Measured: Between 9x24hours and 14x24hours after onset of treatment with a carbapemen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startDec 2014
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
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 Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, FondsNutsOhra
- Responsible party
- Principal investigator, Nick de Jonge, Amsterdam UMC, location VUmc
- Investigators
- Jeroen JWM Janssen, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcMichiel A van Agtmael, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcMark MH Kramer, Prof., MD, Study chair, Amsterdam UMC, location VUmcSonja Zweegman, Prof.,MD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149329
- Sponsor's protocol ID
- 2000735
- Other IDs
- 2014-001546-25, NL48960.029.14, 2014
- Acronym
- SHORT
- Status last verified
- Sep 2019
- First submitted
- 19 May 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Jonge NA, Janssen JJWM, Ypma P, Herbers AHE, de Kreuk A, Vasmel W, van den Ouweland JMW, Beeker A, Visser O, Zweegman S, Blijlevens NMA, van Agtmael MA, Sikkens JJ. Mucositis-associated bloodstream infections in adult haematology patients with fever during neutropenia: risk factors and the impact of mucositis severity. Support Care Cancer. 2024 Aug 8;32(9):579. doi: 10.1007/s00520-024-08776-w.
PubMed 39115709de Jonge NA, Sikkens JJ, Zweegman S, Beeker A, Ypma P, Herbers AH, Vasmel W, de Kreuk A, Coenen JLLM, Lissenberg-Witte B, Kramer MHH, van Agtmael MA, Janssen JJWM. Short versus extended treatment with a carbapenem in patients with high-risk fever of unknown origin during neutropenia: a non-inferiority, open-label, multicentre, randomised trial. Lancet Haematol. 2022 Aug;9(8):e563-e572. doi: 10.1016/S2352-3026(22)00145-4. Epub 2022 Jun 9.
PubMed 35691326
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With Fever of Unknown Origin: a Randomized Multicenter Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT02149329
- Acronym / sponsor ID
- SHORT / 2000735
- Conditions
- Febrile Neutropenia, Hematological Malignancy
- Keywords
- fever, neutropenia, febrile neutropenia, carbapenem, imipenem, meropenem, antibiotic stewardship, hematology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, FondsNutsOhra
- Study start
- Dec 2014 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 29 May 2014 (estimated)
- 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 multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
Detailed description
Episodes of fever are very common in patients undergoing intensive chemotherapy treatment for malignant hematological disease. More than 80% of patients experience one or more episodes of fever after their first cycle of chemotherapy. Only 20-30% of these patients have a clinically documented focus and mostly include infections of skin, intestinal tract and lung, while at most 10-25% of these patients have microbiologically proven bacteremia during these episodes. Patients with malignant hematological diseases and intensive chemotherapy induced neutropenia are extremely prone to overwhelming bacterial infections. Therefore, empirical antibiotic treatment is initiated at the first occurrence of fever, even if no apparent cause for the fever is evident. Most protocols advice treatment with very broad-spectrum antibiotics, mostly anti-pseudomonal carbapenems or fourth generation anti-pseudomonal cephalosporins.
Prolonged continuation of treatment may induce bacterial resistance. In view of the possible emergence of bacterial resistance due to prolonged antibiotic administration, continuation until recovery of neutropenia is suboptimal because it is costly because of longer hospital admissions, higher antibiotics costs and more possible adverse reactions.
Recent observational data (Slobbe et al) has showed that in adult hematological patients with febrile neutropenia, discontinuation of empiric antibacterial therapy after three days can be safe if no infectious etiology can be found, even in cases with persistent fever. However no RCT has hitherto been performed to support this observational data.
This study compares the safety (non-inferiority) of short treatment (72 hours) versus extended treatment (at least 9 days) with an anti-pseudomonal carbapenem for hematology patients with unexplained high risk febrile neutropenia. We hypothesize that a more restrictive use of broad-spectrum antibiotic use of three days in unexplained fever in neutropenic hematology patients is non-inferior to the present extended use during at least 9 days which would lead to a more restrictive use of antibiotics and less multiresistant strains of bacteria, costs and hospitalization length in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment | Experimental | Drug: Discontinuation of imipenem-cilastatin or meropenemDiscontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever. |
| Extended treatment | No intervention | –Extended treatment with imipenem-cilastatin or meropenem for at least 6 more days. The treatment with a carbapenem will be continued until patients have been treated for at least 9x24 hours and have been afebrile (tympanic membrane temperature <38.0°C) for at least five consecutive days or until resolution of neutropenia (ANC > 0,5 x10^9/L), whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
- High-risk neutropenia (Absolute neutrophil count (ANC) <0.5x109/L which is expected to last longer than 7 days);
- Fever (One single measured tympanic membrane temperature of >38.5°C or a temperature of >38.0°C during 2 subsequent measurements separated by at least 2 hours);
- Age 18 years or older;
- Written informed consent.
Key exclusion criteria (7 listed)
- Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
- Corticosteroid use ≥10 mg per day prednisolone or equivalent for more than 3 consecutive day during the previous 7 days.
- Clinically or microbiologically documented infection.
- Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
- Previous enrollment in this study during the same episode of neutropenia.
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 |
|---|---|---|
| Discontinuation of imipenem-cilastatin or meropenemAlso: tienam (imipenem-cilastatin)Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever. | Drug | Short treatment |
Primary outcome
The percentage of patients with failed treatment
Time frame: Between randomization (at 3x24 hours) and before 9x24hours after treatment initiation)
Treatment failure is defined as the occurrence of one of the following events after 3x24 hours and before 9x24hours after treatment initiation with a carbapenem: -A clinically or microbiologically documented carbapenem-sensitive infection; treatment. Recurrence of fever after previous defervescence (tympanic temperature <38.0 °C during 24 hours) which is not attributable to administration of a blood product or to a drug reaction. o In case of clinical doubt whether the fever is of infectious etiology, the recurrence of fever will be considered as failure.
Death/ARDS or Septic shock
Time frame: From randomization until the end of neutropenia (neutrophil count >=0.5x10e9/L) up to 6 months after randomization.
The occurrence of death, ARDS/respiratory insufficiency, septic shock (systolic blood pressure <90 mmHg and oliguria <500 mL/day) due to any cause.
14 secondary outcomes
All-cause mortality.
Time frame: 1. From 3x24hours of treatment until the end of neutropenia. 2. Within 30 days after the end of neutropenia
Infection-related mortality.
Time frame: 1. From 3x24hours of treatment until the end of neutropenia. 2.Within 30 days after recovery of neutropenia
The length of hospitalization in days.
Time frame: From admission until discharge, with an estimated average of 4 weeks
Treatment strategy failure
Time frame: after 3x24hours of treatment with a carbapenem and until the end of the neutropenic episode
The total number of febrile episodes during neutropenia.
Time frame: From the start of neutropenia (ANC<0.5x10^9) until the end of neutropenia, an expected average of 21 days
Time to defervescence
Time frame: Onset of fever until defervenscence, an expected average of 5 days.
Incidence and prevalence of Clostridium difficile infection
Time frame: Onset of fever until 30 days after the end of neutropenia.
Candida spp. colonization in (surveillance) cultures
Time frame: From onset of fever until 30 days after the end of neutropenia.
Cost of antimicrobial therapy per admission
Time frame: From admission until discharge, with an estimated average of 4 weeks
The percentage of patients with a MASCC-score≥21 and treatment failure (defined as in primary endpoint)
Time frame: From the onset of fever until the end of the neutropenic episode, with an estimated average of 21 days.
The percentage of patients with mucositis and positive blood cultures or short treatment failure.
Time frame: From onset of fever until 30 days after end of neutropenia.
Bacterial resistance in blood cultures and surveillance cultures (including minimal inhibitory concentrations (MIC)).
Time frame: All previous cultures and cultures performed until 30 days after the end of neutropenia.
The incidence and prevalence of fungal, viral, or carbapenem-resistant (inherent/acquired) infections until the end of neutropenia
Time frame: om the onset of fever until the end of the neutropenic episode, with an estimated average of 21 days.
Late treatment failure
Time frame: Between 9x24hours and 14x24hours after onset of treatment with a carbapemen.
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 25 Sep 2019.
- Derived from this study: PubMed 39115709de Jonge NA, Janssen JJWM, Ypma P, Herbers AHE, de Kreuk A, Vasmel W, van den Ouweland JMW, Beeker A, Visser O, Zweegman S, Blijlevens NMA, van Agtmael MA, Sikkens JJ. Mucositis-associated bloodstream infections in adult haematology patients with fever during neutropenia: risk factors and the impact of mucositis severity. Support Care Cancer. 2024 Aug 8;32(9):579. doi: 10.1007/s00520-024-08776-w.
- Derived from this study: PubMed 35691326de Jonge NA, Sikkens JJ, Zweegman S, Beeker A, Ypma P, Herbers AH, Vasmel W, de Kreuk A, Coenen JLLM, Lissenberg-Witte B, Kramer MHH, van Agtmael MA, Janssen JJWM. Short versus extended treatment with a carbapenem in patients with high-risk fever of unknown origin during neutropenia: a non-inferiority, open-label, multicentre, randomised trial. Lancet Haematol. 2022 Aug;9(8):e563-e572. doi: 10.1016/S2352-3026(22)00145-4. Epub 2022 Jun 9.
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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.
Jeroen JWM Janssen, MD, PhD principal investigator
Amsterdam UMC, location VUmc
Michiel A van Agtmael, MD, PhD principal investigator
Amsterdam UMC, location VUmc
Mark MH Kramer, Prof., MD study chair
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinuation of imipenem-cilastatin or meropenem in people with Febrile Neutropenia and Hematological Malignancy, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. 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 Netherlands. 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?
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?
The percentage of patients with failed treatment (time frame: Between randomization (at 3x24 hours) and before 9x24hours after treatment initiation)). 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 NCT02149329, 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 25 Sep 2019.