Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia

NCT03824457 | Completed Phase 4

• 1 other identifier: RheoSTAT-CP0698
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 12

Brief Summary

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of pneumonia. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

Conditions

Pneumonia

Keywords

Intoxication

Outcome Measures

Primary Outcomes (1)

• A change in the total SOFA score vs. baseline score upon admission;

  Sequential Organ Failure Assessment (SOFA) score is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure. The SOFA score ranges from 0 to 24 points. We evaluate initial SOFA score and differences between subsequent scores (Δ-SOFA scores).

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

Secondary Outcomes (37)

• A change in the total APACHE II score vs. baseline score upon admission;

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total SAPS II score vs. baseline score upon admission;

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total MODS score vs. baseline score upon admission;

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total PSI/PORT score vs. baseline score upon admission

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total CURB-65 score vs. baseline score upon admission

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse events.

  Patients will be followed during 14 days.

• Incidence of multiple organ failure.

  Patients will be followed during 14 days.

• Overall survival (%) at follow-up visit.

  Patients will be followed during 14 days.

Study Arms (2)

Rheosorbilact®

EXPERIMENTAL

Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours). The period of the treatment with the study drug lasts 3 days.

Drug: Rheosorbilact®

Ringer lactate

ACTIVE COMPARATOR

Ringer's Lactate is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours).The period of the treatment with the active comparator lasts 3 days.

Drug: Ringer lactate

Interventions

Rheosorbilact® DRUG

Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours) for 3 days.

Rheosorbilact®

Ringer lactate DRUG

Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours) for 3 days.

Ringer lactate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 45 years inclusive;
• Community-acquired pneumonia with a prescription from the beginning of antibacterial therapy no more than 48 hours;
• The risk class of pneumonia in the PSI/PORT index score is at least IV;
• Informed consent for participation in the study signed by subject's own hand.
• The baseline value of the SOFA scale ≥ 2 points.
• Individual intolerance of the components of the study drug and reference preparation;
• Hypersensitivity to sodium lactate;
• Intravenous infusions of lactate- or sorbitol-containing products within 24 hours before enrollment;
• Severe renal dysfunction (creatinine is more than 300 μmol/l or estimated creatinine clearance is less than 30 ml/min);
• Pregnancy or breast-feeding;
• Metabolic alkalosis;
• Severe metabolic acidosis;
• Intracerebral hemorrhage;
• Any thromboembolism;
• Decompensated cardiovascular failure;

You may not qualify if:

• Infusion of the study drug or the comparator is started more than 12 hours after randomization;
• Lack of data for community-acquired pneumonia (diagnosis not confirmed);
• Withdrawal of the informed consent by the subject;
• Investigator considers that the infusion therapy with either study drug or comparator may not be continued for safety reasons;
• Development of conditions that prevent further use of the study drug/comparator before efficacy evaluation visit (Visit 3);
• Subject needs concomitant therapy prohibited in the study before efficacy evaluation visit (Visit 3);
• Development of conditions (including serious adverse events) which make it impossible to evaluate the primary endpoint;
• Confirmation of pregnancy at any time of the study.

Sponsors & Collaborators

• Yuria-Pharm: lead

Study Sites (12)

"Unimedi Adjara" LLC

Batumi, Georgia

Location

JSC EVEX Medical corporation/Kutaisi Referral Hospital

Kutaisi, Georgia

Location

"Israel Georgian Medical Research Clinic HELSI Core LLC" LTD.

Tbilisi, Georgia

Location

Hospital of the Medical Center Office of the President's Affairs Republic of Kazakhstan

Astana, Kazakhstan

Location

Municipal Clinical Hospital "Sfinta Treime"

Chisinau, Moldova

Location

Municipal Clinical Hospital

Chisinau, Moldova

Location

National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine

Kyiv, Ukraine

Location

City Hospital №1

Mykolayiv, Ukraine

Location

Vinnitsa National Medical University; City Clinical Hospital №1

Vinnitsa, Ukraine

Location

Republican Scientific Center of Emergency Medical Aid

Tashkent, Uzbekistan

Location

198 Hospital

Hanoi, Vietnam

Location

Thai Binh University of Medicine and Pharmacy

Thái Bình, Vietnam

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will perform the assessment of primary, secondary efficasy and safety parameters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: January 8, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: February 18, 2020

Record last verified: 2019-10

Locations

UA (3); UZ (1); GE (3); VN (2); KA (1); MO (2)