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Community Acquired PneumoniaPhase 2CIGMANCT01420744

Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP

A Phase 2 study testing BT086 and 1% Human Albumin infusion in people with Community Acquired Pneumonia, run by Biotest at 36 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine whether the adjunctive therapy to standard antibiotic treatment of BT086 is safe and effective of decreasing the days patients require endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community Acquired Pneumonia
What is being tested?
BT086 and 1% Human Albumin infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
36 sitesin 4 countries
Study dates
Aug 2011to Apr 2015
Phase
Phase 2
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

  • Written informed consent:
  • given by the patient or
  • a legal/authorised representative of the patient or
  • a waiver for written informed consent due to emergency situation, in compliance with all local legal requirements.
  • Male or female patients aged 18 years or older
  • Patient receiving adequate antibiotic treatment for pneumonia
Show all 19Show fewer
  • Prior to endotracheal ventilation and therapy, the patient must have at least one of the following two signs of inflammation:
  • Fever/Hypothermia Fever defined as an oral, tympanic, oesophageal or vesical temperature of >38°C, tympanic temperature of >38°C or rectal temperature of >38.5°C, or hypothermia (rectal temperature <35.5°C) (measurement with temperature probe or device) or
  • White blood cell (WBC) count >10,000/mm³ or WBC <4,500/mm³
  • Patient must have at least one of the following signs and symptoms of pneumonia:
  • New or increased cough
  • Production of purulent sputum or change in sputum characteristics
  • Dyspnoea or tachypnoea (respiratory rate >20 breaths/minute)
  • Pleuritic chest pain
  • Auscultatory findings on pulmonary examination of rales and/or crackles and/or evidence of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds, or egophony)
  • Radiological (or other imaging technique) evidence of (an) infiltrate(s) consistent with bacterial pneumonia
  • Pneumonia has been acquired outside the hospital. In hospital-admitted patients, pneumonia has been diagnosed a maximum of 72 hours after admission. Patients from nursing homes or similar institutions are eligible.
  • Major sCAP criterion: need for endotracheal ventilation
  • Treatment of patient with BT086 must start within 12 hours but not earlier than 1 hour after start of endotracheal ventilation

Who cannot join

  • For incapacitated patients: any indication that the patient's presumed will would be against inclusion in the trial
  • Patients with suspected hospital-acquired pneumonia
  • Severe lung diseases interfering with sCAP therapy e.g. patients with cystic fibrosis,
  • Patients receiving Xigris® (drotrecogin alfa, activated Protein C) or medications not approved for sCAP (e.g. Dornase alpha) are excluded from inclusion in the study
  • Patients on dialysis
  • Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing uncorrectable medical condition).
Show all 12Show fewer
  • Patients unable to be treated due to obesity
  • Selective, absolute IgA deficiency with known antibodies to IgA
  • Patients with neutrophil count <1,000/mm³ or platelet count <50,000/mm³
  • Pregnant or lactating women. A pregnancy test will be performed in all women aged <65 years and the result must be available at study inclusion.
  • Known relevant intolerance to immunoglobulins, vaccines or other substances of human origin
  • Participation in another interventional clinical trial within 30 days before entering the study or during the study, and/or previous participation in this study (participation in non-interventional trials is allowed).

Trial locations and contacts

36 sites in 4 countries.

36 sites in 4 countries

Germany17 sites

  • 108

    Berlin

  • 114

    Chemnitz

  • 118

    Cologne

  • 119

    Cologne

  • 110

    Dresden

  • 111

    Erfurt

  • 116

    Frankfurt

  • 117

    Greifswald

  • 103

    Halle

  • 115

    Hamburg

  • 101

    Hanover

  • 107

    Homburg/Saar

  • 109

    Lübeck

  • 106

    Marburg

  • 120

    Stuttgart

  • 105

    Tübingen

  • 113

    Wuppertal

Other trials in Germany

Spain12 sites

  • 213

    Badalona

  • 201

    Barcelona

  • 206

    Barcelona

  • 204

    Girona

  • 207

    Madrid

  • 208

    Mataró

  • 210

    Palma de Mallorca

  • 212

    Sabadell

  • 209

    Santiago de Compostela

  • 205

    Tarragona

  • 211

    Terrassa

  • 203

    Valencia

Other trials in Spain

United Kingdom6 sites

  • 303

    Cardiff

  • 304

    Kings Lynn, Norfolk

  • 301

    London

  • 306

    London

  • 302

    Poole, Dorset

  • 305

    Reading, Berkshire

Other trials in United Kingdom

Belgium1 site

  • 401

    Brussels

Other trials in Belgium

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)

The purpose of this study is to determine whether the adjunctive therapy to standard antibiotic treatment of BT086 is safe and effective of decreasing the days patients require endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).

Read the detailed description

Severe Community-Acquired Pneumonia (sCAP) is usually defined clinically as pneumonia acquired from outside the hospital (CAP) that requires intensive medical care. Mortality of (s)CAP patients admitted to ICU range from 35-58% depending on time and admission of the patient and has not much improved in the last years.

BT086 contains a sufficient number of antibodies against the most frequent pathogens as well as antibodies against lipopolysaccharides and lipid A. Therefore, it can be assumed that administration of BT086 early in the clinical course of a severe infection such as sCAP may provide an effective adjunctive treatment to standard antibiotic therapy for sCAP patients.

Being tested
BT086, 1% Human Albumin infusion
Keywords
Endotracheal ventilation, Bacterial pneumonia
Medical subject headings
Community-Acquired Pneumonia, Pneumonia, Bacterial

What participants receive

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

  • BT086Drug

    BT086 will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day and is calculated by the mean Immunoglobulin M (IgM) content of BT086 which is 23%.

    Infusion rate:

    Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate) Treatment will be administered over a 5-day period.

  • 1% Human Albumin infusionDrug

    1% Albumin will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day.

    Infusion rate:Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate). Rate is to be raised in steps of 0.1 mL every 10 min until the target infusion rate is reached.

    Treatment will be administered over a 5-day period.

    Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate)

Study groups in NCT01420744
Study groupRoleWhat they receive
BT086 infusionExperimentalNot described
Receives: Drug: BT086
1% Human Albumin infusionPlacebo comparatorNot described
Receives: Drug: 1% Human Albumin infusion

What is being measured

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

  1. Ventilator Free Days (VFDs)

    VFDs are defined as the number of days between successful weaning from endotracheal ventilation and day 28 after study enrolment.

    Measured: 28 days

Secondary outcomes (7)

  1. 28-day all cause mortality

    All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28", regardless of cause of death.

    Measured: 28 days (672 hours from randomization)

  2. 28-day pneumonia-cause mortality

    All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28, with pneumonia as cause of death".

    Measured: 28 days (672 hours from randomization)

  3. Time (days) to discharge from ICU

    The date and time of admission to and discharge from the ICU will be recorded in the Case Report Form (CRF). The time to discharge from the ICU will be calculated as the number of days spent in the ICU.

    Measured: 28 days

  4. Time (days) to discharge from hospital

    The date and time of admission to and discharge from the hospital will be recorded in the CRF. The time to discharge from the hospital will be calculated as the number of days spent in the hospital.

    Measured: 28 days

  5. SOFA: Score Sequential Organ Failure Assessment

    Each organ system (cardiovascular, haematology, hepatic, renal, respiratory) will be scored using the SOFA methodology.For analysis, a patient will receive a score on each day (Study Days 1-7, Day 14, Day 21, and Day 28). Mean changes in organ function scores over time and percentages of patients whose organ function has resolved will be compared between treatment groups.

    Measured: 28 days

  6. Vasopressor-free days

    Vasopressor-free days will be calculated in a similar manner to VFDs, as described above. Vasopressors include dobutamine, epinephrine, dopamine, and norepinephrine.

    A day is considered as a vasopressor-free day if a patient does not receive

    • Dobutamine >2.5 µg/kg/min or/and
    • Epinephrine (adrenalin) >=2.5 µg/min or/and
    • Dopamine >=2.5 µg/kg/min or/and
    • Norepinephrine >=0.014 µg/kg/min for 4 hours per day.

    Measured: 28 days

  7. Glasgow Coma Score

    The Glasgow Coma Scale will be scored using the Glasgow Coma Score methodology. The patient will be assessed by calculating the score on each study day (Day -1 through to Day 28).

    Measured: 28 days

Timeline

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

  1. First posted22 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionFeb 2015
  4. Study completionApr 2015

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01420744
Sponsor's protocol ID
CIGMA Study 982
Acronym
CIGMA
Status last verified
Jul 2015
First submitted
19 Aug 2011
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Jahn K, Handtke S, Palankar R, Weissmuller S, Nouailles G, Kohler TP, Wesche J, Rohde M, Heinz C, Aschenbrenner AF, Wolff M, Schuttrumpf J, Witzenrath M, Hammerschmidt S, Greinacher A. Pneumolysin induces platelet destruction, not platelet activation, which can be prevented by immunoglobulin preparations in vitro. Blood Adv. 2020 Dec 22;4(24):6315-6326. doi: 10.1182/bloodadvances.2020002372.

    PubMed 33351126

  • Welte T, Dellinger RP, Ebelt H, Ferrer M, Opal SM, Singer M, Vincent JL, Werdan K, Martin-Loeches I, Almirall J, Artigas A, Ignacio Ayestaran J, Nuding S, Ferrer R, Sirgo Rodriguez G, Shankar-Hari M, Alvarez-Lerma F, Riessen R, Sirvent JM, Kluge S, Zacharowski K, Bonastre Mora J, Lapp H, Wobker G, Achtzehn U, Brealey D, Kempa A, Sanchez Garcia M, Brederlau J, Kochanek M, Reschreiter HP, Wise MP, Belohradsky BH, Bobenhausen I, Dalken B, Dubovy P, Langohr P, Mayer M, Schuttrumpf J, Wartenberg-Demand A, Wippermann U, Wolf D, Torres A. Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study). Intensive Care Med. 2018 Apr;44(4):438-448. doi: 10.1007/s00134-018-5143-7. Epub 2018 Apr 9.

    PubMed 29632995

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BT086 and 1% Human Albumin infusion in people with Community Acquired Pneumonia, run by Biotest at 36 sites in 4 countries.

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 19 inclusion and 12 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany, Spain, United Kingdom, Belgium. 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 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.

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?

Ventilator Free Days (VFDs) (time frame: 28 days). 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 NCT01420744, 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 29 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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