Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03334006 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis

Study acronym: PEPPER
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 3 of 20 sitesv19
  2. Study sites: 19 to 20
    • Secondary endpoints revised (4)
    • Eligibility criteria shortened, about 4 words
    • Study description expanded, about 2 words
    v18
  3. Site details revised at 1 of 19 sitesv17
  4. Study sites: 18 to 19v16
  5. Study sites: 16 to 18v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 5 of 16 sites
    • Study title shortened, about 2 words
    v14
  2. Study sites: 15 to 16
    • Study title shortened, about 1 word
    v13
  3. Trial status: Suspended to Recruitingv12 Show 9 more changesShow less
    • Primary completion date: Sep 2026 to Sep 2027
    • Primary endpoint revised
    • Study sites: 12 to 15
    • Study completion date: Jan 2027 to Mar 2028
    • Interventions: Pentaglobin® (Drug) to Pentaglobin®/Standard of Care (Drug)
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 36 words
    • Study title revised
  4. Primary completion date: Aug 2021 to Sep 2026
    • Study completion date: Dec 2021 to Jan 2027
    v11
  5. Re-verified, no change to tracked fieldsv10
  6. Trial status: Recruiting to Suspended Sponsor's reason: Due to safety-relevant aspects with regard to internal processes of the sponsor
    • Study sites: 13 to 12
    v9
  7. Study sites: 1 to 13v8
  8. Primary completion date: Nov 2020 to Aug 2021v7 Show 4 more changesShow less
    • Study completion date: Apr 2021 to Dec 2021
    • Eligibility criteria expanded, about 25 words
    • Site contact updated
    • Study title shortened, about 4 words
  9. Re-verified, no change to tracked fieldsv6
  10. Study title expanded, about 7 wordsv5
  11. Start date changed from estimate of Nov 2017 to Nov 20, 2017v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  13. Study title expanded, about 6 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, NF-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.
Trial Details
NCT Number NCT03334006
Lead Sponsor RWTH Aachen University
Collaborators: Biotest
Conditions
(from sponsor)		 Peritonitis, Sepsis, Septic Shock
Related terms Peritonitis, Sepsis, Shock, Septic
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov