Severe SepsisPhase 2/3MISSNCT02025660
Efficacy of Mw Vaccine in Treatment of Severe Sepsis
A Phase 2/3 study testing Mw, 0.3ml x three days sc in people with Severe Sepsis and Septic Shock, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis. Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Sepsis, Septic Shock, Immune Modulation
- What is being tested?
- Mw, 0.3ml x three days sc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2013to Mar 2014
- Phase
- Phase 2/3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- All consecutive patients admitted in respiratory intensive care unit of our Institute with severe sepsis or septic shock fulfilling the following criteria will be included in the study after taking the informed consent:
- Any patient of severe sepsis or septic shock as defined below:
- Systemic Inflammatory Response Syndrome (SIRS): Two or more of the following conditions: temperature >38.5°C or <36.0°C; heart rate of >90 beats/min; respiratory rate of >20 breaths/min or PaCO2 of <32 mm Hg; and WBC count of >12,000 cells/mL or <4000 cells/mL, or >10 percent immature (band) forms
- Sepsis: SIRS in response to presumed or documented infection (culture or Gram stain of blood, sputum, urine, or normally sterile body fluid positive for pathogenic microorganism; or focus of infection identified by visual inspection, e.g., ruptured bowel with free air or bowel contents found in abdomen at surgery, wound with purulent discharge, consolidation on chest radiograph).
- Severe sepsis: Sepsis and at least one of the following signs of organ hypoperfusion or organ dysfunction: areas of mottled skin; capillary refilling of 3 s; urinary output of <0.5 mL/kg for at least 1 h or renal replacement therapy; lactate >2 mmol/L; abrupt change in mental status or abnormal EEG findings; platelet count of <100,000 cells/mL or disseminated intravascular coagulation; acute lung injury/ARDS; and cardiac dysfunction (echocardiography)
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- Septic shock: Severe sepsis and one of the following conditions: Systemic mean BP of <60 mm Hg (<80 mm Hg if previous hypertension) after 40 to 60 mL/kg saline solution, or PCWP between 12 and 20 mm Hg; and Need for dopamine of >5 mcg/kg/min, or norepinephrine or epinephrine of <0.25 mcg/kg/min to maintain mean BP at >60 mm Hg (80 mm Hg if previous hypertension)
- Refractory septic shock: Need for dopamine at >15 mcg/kg/min, or nor-epinephrine or epinephrine at >0.25 mcg/kg/min to maintain mean BP at >60 mm Hg (80 mm Hg if previous hypertension)
- AND having at least one of the following:
- Source of Gram negative sepsis presumed to be originating from these sources (gastrointestinal, hepatobiliary, genitourinary tract, pulmonary, neurological) or
- Documented by typical clinical signs and symptoms and confirmed by blood culture and/or histology or
- Documented by typical clinical signs and symptoms and confirmed by CSF culture/tissue culture and/or histology or
- Positive culture or histology confirmation or any other investigation deemed necessary must be obtained at the time of enrolment and prior to the first dose of study medication
- Patients and/or legally authorized representative(s), if applicable, have been fully informed and have given written informed consent. A patient unable to write and /or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
- Patients of either gender in the age range of 18-65 years
- Female patients of child bearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. They must avoid becoming pregnant while receiving study medication by maintaining adequate birth control practice
- Patients must have sufficient venous access to permit administration of medication and monitoring of safety variables.
Who cannot join
- 1. Blood culture is positive for Gram-positive organism. 2. Patient is pregnant or nursing. 3. Patients whose sole diagnosis is fungal sepsis. 4. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication.
- 5. Patient previously enrolled into this study. 6. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- 7. Patients with a concomitant medical condition, whose participation may create an unacceptable additional risk.
- 8. Patients with a life expectancy judged to be less than five days from the basic disease other than sepsis.
- 9. History of cardiopulmonary resuscitation for the current episode of sepsis 10. Patients not willing to participate or not likely to complete the trial as per judgement of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Immune-modulation Improve the Survival in Patients With Severe Sepsis? "A Proof of the Concept Study"
Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis.
Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following
- Mortality in the two arms
- Daily SOFA scores
- Ventilator free days
- Time-to-vasopressor withdrawal
- ICU length of stay
- Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
Read the detailed description
This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. The study will be conducted in the respiratory intensive care unit at PGIMER, Chandigarh, over a period of 1 year. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
In addition to the standard therapy for sepsis, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal for 3 consecutive days.
Study Duration Study duration for each patient will be 28 days. Follow up period is included in the study duration of 28 days
Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and randomized to one of the treatment arms. The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite
- Conditions
- Severe Sepsis, Septic Shock, Immune Modulation
- Being tested
- Mw, 0.3ml x three days sc, Placebo
- Keywords
- Mw, Mycobacterium indicum prannii, Mycobacterium w, Severe sepsis, Septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mw, 0.3ml x three days scDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mw | Experimental | Not described Receives: Drug: Mw, 0.3ml x three days sc |
| Saline; 0.3 ml x three days sc | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: upto 4 weeks
Secondary outcomes (1)
Hospital length of stay
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Inderpaul si Sehgal, Principal investigator, PIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025660
- Sponsor's protocol ID
- IP 39
- Acronym
- MISS
- Status last verified
- Mar 2014
- First submitted
- 25 Dec 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Immune-modulation Improve the Survival in Patients With Severe Sepsis? "A Proof of the Concept Study"
- ClinicalTrials.gov ID
- NCT02025660
- Acronym / sponsor ID
- MISS / IP 39
- Conditions
- Severe Sepsis, Septic Shock, Immune Modulation
- Keywords
- Mw, Mycobacterium indicum prannii, Mycobacterium w, Severe sepsis, Septic shock
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Jan 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.
Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis.
Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following
- Mortality in the two arms
- Daily SOFA scores
- Ventilator free days
- Time-to-vasopressor withdrawal
- ICU length of stay
- Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
Detailed description
This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. The study will be conducted in the respiratory intensive care unit at PGIMER, Chandigarh, over a period of 1 year. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
In addition to the standard therapy for sepsis, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal for 3 consecutive days.
Study Duration Study duration for each patient will be 28 days. Follow up period is included in the study duration of 28 days
Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and randomized to one of the treatment arms. The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mw | Experimental | Drug: Mw, 0.3ml x three days sc |
| Saline; 0.3 ml x three days sc | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- -
- All consecutive patients admitted in respiratory intensive care unit of our Institute with severe sepsis or septic shock fulfilling the following criteria will be included in the study after taking the informed consent:
- Any patient of severe sepsis or septic shock as defined below:
- AND having at least one of the following:
- Patients and/or legally authorized representative(s), if applicable, have been fully informed and have given written informed consent. A patient unable to write and /or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
Key exclusion criteria (5 listed)
- 1. Blood culture is positive for Gram-positive organism. 2. Patient is pregnant or nursing. 3. Patients whose sole diagnosis is fungal sepsis. 4. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication.
- 5. Patient previously enrolled into this study. 6. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- 7. Patients with a concomitant medical condition, whose participation may create an unacceptable additional risk.
- 8. Patients with a life expectancy judged to be less than five days from the basic disease other than sepsis.
- 9. History of cardiopulmonary resuscitation for the current episode of sepsis 10. Patients not willing to participate or not likely to complete the trial as per judgement of the investigator.
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 |
|---|---|---|
| Mw, 0.3ml x three days sc | Drug | Mw |
| Placebo | Drug | Saline; 0.3 ml x three days sc |
Primary outcome
Mortality
Time frame: upto 4 weeks
1 secondary outcome
Hospital length of stay
Time frame: upto 4 weeks
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 20 Mar 2014.
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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.
Inderpaul si Sehgal principal investigator
PIMER, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mw, 0.3ml x three days sc in people with Severe Sepsis and Septic Shock, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 17 inclusion and 5 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 20 Mar 2014. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mortality (time frame: upto 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.