Digestive System NeoplasmsPNASITNCT03115957

Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

A study testing Parenteral Nutrition in people with Digestive System Neoplasms, run by Jinling Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Digestive System Neoplasms
What is being tested?: Parenteral Nutrition
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 1 siteChina
Study dates: 14 Apr 2017to 22 Feb 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent of patients or their legal representatives to participate in this study.
Patients undergoing selective operation without trauma
Patients following medium or major abdominal surgery
NRS 2002≥ 3

Who cannot join

Psychiatric disorders
Pregnancy or breast-feeding women
Malnutrition
Weight loss >10%-15% in 6 months
BMI<18.5
SGA score with stage C

Show all 36Show fewer

Albumin <30g/L
Unstable vital signs or unstable hemodynamics (such as systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg after rapid 500 ml crystal or 200 ml gel infusion, or the 50% increase of vascular active drug infusion rate in an hour, etc)
Refuse to participate in the study
Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases
Cancer in terminal stage
HIV positive at end-stage or CD4 < 50/mm3
Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery
Four levels of physical activity of the patients defined by New York heart association
Rely on breathing machine because of chronic diseases
Life expectancy less than 24 hours of dying patients
Refractory shock to meet any of the following article
The infusion rate of dopamine > 15 ug/kg/min
The infusion rate of dobutamine > 15 ug/kg/min
The infusion rate of epinephrine and norepinephrine > 30 ug/min
The infusion rate of phenylephrine > 50 ug/min
The infusion rate of milrinone > 0.5 ug/kg/min
The infusion rate of vasopressin > 0.04 U/min
Inter aortic ballon pump (IABP)
Hepatic insufficiency (alanine/aspartate transaminase 200% above normal range)
Renal insufficiency(creatinine 200% above normal range)
Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders)
EN can reach 30% of target energy in 48 hours after surgery
Burn area exceeding 20% of the patient's body surface
Autoimmune diseases or immune dysfunction or history of organ transplantation
International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis
Intracranial hemorrhage one month before enrolment
General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition
Has already participated in another clinical trial
Has started to nutritional support therapy before enrolment
Diabetes mellitus (anamnestic and/or under medical treatment)

Trial locations and contacts

1 site in 1 country.

China1 site

JinlingH
Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial

Patients will be randomized to early PN group or late PN group at day 3 after abdominal surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Read the detailed description

Patients after abdominal surgery will attempt enteral nutrition support for 2 days, if she/he can not tolerate 30% of target energy, then she/he will be randomized to early PN group or late PN group at day 3. Patients in early PN group will receive supplemental parenteral nutrition at day 3 while patients in late PN group will not receive supplemental parenteral nutrition until day 8 after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Conditions: Digestive System Neoplasms
Being tested: Parenteral Nutrition
Keywords: Parenteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trials, Clinical Outcomes, Postoperative Period
Medical subject headings: Digestive System Neoplasms, Hyperphagia

What participants receive

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

Parenteral NutritionOther
Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.

Study groups in NCT03115957
Study group	Role	What they receive
Early PN	Experimental	Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery. Receives: Other: Parenteral Nutrition
Delayed PN	Experimental	Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery. Receives: Other: Parenteral Nutrition

What is being measured

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

Morbidity of infection
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases
Measured: From date of randomization until the date of infection from any cause, assessed up to 2 months.

Secondary outcomes (5)

Length of stay in hospital
The length of patients stay in hospital after operation
Measured: From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
Mortality
All deaths reported in all enrolled patients.
Measured: From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.
Scale the frequency of gastrointestinal intolerance
Diarrhea, vomiting, abdominal distention or cramping and abdominal pain
Measured: During the intervention, assessed up to 2 months.
Scale actual calories intake
The total energy patients received during the intervention
Measured: During the intervention, assessed up to 2 months.
Laboratory examination
Albumin, pre-albumin, transferrin and retinol conjugated protein
Measured: At the date of patients enrollment and after intervention, assessed up to 2 months.

Timeline

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

14 Apr 201722 Feb 2019

First posted14 Apr 2017
Study start14 Apr 2017
Primary completion30 Dec 2018
Study completion22 Feb 2019

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 Digestive System NeoplasmsStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03115957
Sponsor's protocol ID: 201502022-22
Acronym: PNASIT
Status last verified: Sep 2020
First submitted: 30 Mar 2017
Last updated: 29 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bauer P, Charpentier C, Bouchet C, Nace L, Raffy F, Gaconnet N. Parenteral with enteral nutrition in the critically ill. Intensive Care Med. 2000 Jul;26(7):893-900. doi: 10.1007/s001340051278.
PubMed 10990103
Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, Francois B. Initial efficacy and tolerability of early enteral nutrition with immediate or gradual introduction in intubated patients. Intensive Care Med. 2008 Jun;34(6):1054-9. doi: 10.1007/s00134-007-0983-6. Epub 2008 Jan 22.
PubMed 18210092
Arabi YM, Tamim HM, Dhar GS, Al-Dawood A, Al-Sultan M, Sakkijha MH, Kahoul SH, Brits R. Permissive underfeeding and intensive insulin therapy in critically ill patients: a randomized controlled trial. Am J Clin Nutr. 2011 Mar;93(3):569-77. doi: 10.3945/ajcn.110.005074. Epub 2011 Jan 26.
PubMed 21270385
Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
PubMed 21714640
Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
PubMed 21242788
Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
PubMed 21340655
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
PubMed 22307571
Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
PubMed 23689848
Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
PubMed 23218813
Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.
PubMed 24722769
Charles EJ, Petroze RT, Metzger R, Hranjec T, Rosenberger LH, Riccio LM, McLeod MD, Guidry CA, Stukenborg GJ, Swenson BR, Willcutts KF, O'Donnell KB, Sawyer RG. Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1337-43. doi: 10.3945/ajcn.114.088609. Epub 2014 Sep 3.
PubMed 25332331
Peake SL, Davies AR, Deane AM, Lange K, Moran JL, O'Connor SN, Ridley EJ, Williams PJ, Chapman MJ; TARGET investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Use of a concentrated enteral nutrition solution to increase calorie delivery to critically ill patients: a randomized, double-blind, clinical trial. Am J Clin Nutr. 2014 Aug;100(2):616-25. doi: 10.3945/ajcn.114.086322. Epub 2014 Jul 2.
PubMed 24990423
Petros S, Horbach M, Seidel F, Weidhase L. Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial. JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):242-9. doi: 10.1177/0148607114528980. Epub 2014 Apr 3.
PubMed 24699555
Gao X, Zhang Y, Xiao Y, Gao T, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Zhang L, Wang X. Early versus late supplemental parenteral nutrition in gastrointestinal cancer patients undergoing major abdominal surgery: 5-year outcomes from a randomized clinical trial. Int J Surg. 2026 Mar 12;112(4):9779-9786. doi: 10.1097/JS9.0000000000004504. eCollection 2026 Apr.
PubMed 42682285
Gao X, Zhang Y, Qi X, Xiao Y, Gao T, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Zhang L, Wang X. Early enteral nutrition versus early supplemental parenteral nutrition in patients undergoing major abdominal surgery: a secondary analysis of 2 randomized clinical trials. Am J Clin Nutr. 2024 Apr;119(4):1036-1043. doi: 10.1016/j.ajcnut.2024.02.006. Epub 2024 Feb 17.
PubMed 38369126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial
ClinicalTrials.gov ID: NCT03115957
Acronym / sponsor ID: PNASIT / 201502022-22
Conditions: Digestive System Neoplasms
Keywords: Parenteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trials, Clinical Outcomes, Postoperative Period
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Jinling Hospital, ChinaUniversity, hospital or other
Collaborators: Peking Union Medical College Hospital, Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xijing Hospital, West China Hospital, Xinqiao Hospital of Chongqing, Second Affiliated Hospital, Zhejiang University, School of Medicine, Changhai Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Kunming Medical University
Study start: 14 Apr 2017 (actual)
Primary completion: 30 Dec 2018 (actual)
Study completion: 22 Feb 2019 (actual)
First posted: 14 Apr 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Early PN	Experimental	Other: Parenteral NutritionPatients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.
Delayed PN	Experimental	Other: Parenteral NutritionPatients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Informed consent of patients or their legal representatives to participate in this study.
Patients undergoing selective operation without trauma
Patients following medium or major abdominal surgery
NRS 2002≥ 3

Key exclusion criteria (36 listed)

Psychiatric disorders
Pregnancy or breast-feeding women
Malnutrition
Unstable vital signs or unstable hemodynamics (such as systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg after rapid 500 ml crystal or 200 ml gel infusion, or the 50% increase of vascular active drug infusion rate in an hour, etc)
Refuse to participate in the study

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
Parenteral NutritionPatients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.	Other	Delayed PN, Early PN

Primary outcome

Morbidity of infection
Time frame: From date of randomization until the date of infection from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases

5 secondary outcomes

Length of stay in hospital
Time frame: From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
Mortality
Time frame: From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.
Scale the frequency of gastrointestinal intolerance
Time frame: During the intervention, assessed up to 2 months.
Scale actual calories intake
Time frame: During the intervention, assessed up to 2 months.
Laboratory examination
Time frame: At the date of patients enrollment and after intervention, assessed up to 2 months.

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 29 Sep 2020.
Background: PubMed 10990103Bauer P, Charpentier C, Bouchet C, Nace L, Raffy F, Gaconnet N. Parenteral with enteral nutrition in the critically ill. Intensive Care Med. 2000 Jul;26(7):893-900. doi: 10.1007/s001340051278.
Background: PubMed 18210092Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, Francois B. Initial efficacy and tolerability of early enteral nutrition with immediate or gradual introduction in intubated patients. Intensive Care Med. 2008 Jun;34(6):1054-9. doi: 10.1007/s00134-007-0983-6. Epub 2008 Jan 22.
Background: PubMed 21270385Arabi YM, Tamim HM, Dhar GS, Al-Dawood A, Al-Sultan M, Sakkijha MH, Kahoul SH, Brits R. Permissive underfeeding and intensive insulin therapy in critically ill patients: a randomized controlled trial. Am J Clin Nutr. 2011 Mar;93(3):569-77. doi: 10.3945/ajcn.110.005074. Epub 2011 Jan 26.
Background: PubMed 21714640Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
Background: PubMed 21242788Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
Background: PubMed 21340655Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
Background: PubMed 22307571National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
Background: PubMed 23689848Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
Background: PubMed 23218813Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
Background: PubMed 24722769Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.
Background: PubMed 25332331Charles EJ, Petroze RT, Metzger R, Hranjec T, Rosenberger LH, Riccio LM, McLeod MD, Guidry CA, Stukenborg GJ, Swenson BR, Willcutts KF, O'Donnell KB, Sawyer RG. Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1337-43. doi: 10.3945/ajcn.114.088609. Epub 2014 Sep 3.
Background: PubMed 24990423Peake SL, Davies AR, Deane AM, Lange K, Moran JL, O'Connor SN, Ridley EJ, Williams PJ, Chapman MJ; TARGET investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Use of a concentrated enteral nutrition solution to increase calorie delivery to critically ill patients: a randomized, double-blind, clinical trial. Am J Clin Nutr. 2014 Aug;100(2):616-25. doi: 10.3945/ajcn.114.086322. Epub 2014 Jul 2.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xinying Wang, MD principal investigator

Jinling Hospital, China

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

Questions about this trial

What is this clinical trial studying?

A study testing Parenteral Nutrition in people with Digestive System Neoplasms, run by Jinling Hospital, China at 1 site in China.

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 4 inclusion and 36 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 29 Sep 2020. 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 China. 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?

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?

Morbidity of infection (time frame: From date of randomization until the date of infection from any cause, assessed up to 2 months.). 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 NCT03115957, 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 29 Sep 2020.