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Efficacy and safety of phlogenzym--a protease formulation, in sepsis in children
S K Shahid1, N H Turakhia, M Kundra
1LTMMC and LTMG Hospital and Medical College, Mumbai.
Insights
Phlogenzym, an oral enzyme formulation, demonstrated effectiveness in improving pediatric sepsis recovery. This adjuvant therapy, alongside antibiotics, accelerated fever reduction and reduced the need for hemodynamic support in children.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Infectious Diseases
Background:
- Sepsis is a life-threatening condition caused by the host's inflammatory response to infection.
- Proteolytic enzymes may modulate immune responses and aid recovery from sepsis.
Purpose of the Study:
- To evaluate the efficacy and safety of Phlogenzym as an adjuvant therapy for pediatric sepsis.
- Phlogenzym contains bromelain, trypsin, and rutin.
Main Methods:
- A double-blind, randomized, controlled phase III study was conducted.
- 60 children (1 month to 12 years) with sepsis received either Phlogenzym or placebo for 14-21 days, along with standard treatment.
Main Results:
- Phlogenzym significantly reduced fever duration (3 vs 4 days) and need for hemodynamic support (2 vs 3 days).
- Recovery of Glasgow Coma Scale scores and initiation of oral feeds showed trends towards improvement with Phlogenzym.
- Mortality was observed only in the placebo group.
Conclusions:
- Phlogenzym is effective and safe as an adjuvant therapy for pediatric sepsis.
- It aids in the early improvement of sepsis patients when used with antibiotics and supportive care.
Background:
Infections are a major cause of hospitalisation wherein the host mounts an inflammatory response against the infecting agent. Administration of proteolytic enzymes could regulate the host's immune system and help early recovery from sepsis.
Objective:
To test the efficacy and safety of an oral enzyme formulation, Phlogenzym (Mucos Pharma GmbH, Geretsried, Germany; constituents of each enteric-coated tablet were bromelain 90 mg, trypsin 48 mg, rutin 100 mg) as adjuvant therapy in treatment of sepsis in children.
Subjects And Methods:
Double-blind, randomised, controlled phase III study at a tertiary care centre wherein 60 eligible children aged one month to 12 years with sepsis were randomised to receive either phlogenzym (n=30; 17 boys) or placebo (n=30; 22 boys) tablets (1 tablet/10 kg body weight up to maximum six tablets a day in two or three divided doses for 14-21 days) along with appropriate antibiotics and supportive treatment.
Results:
Median time taken for fever to subside was three days (range 1-12; 95% CI--1.14 to 7.14) in the phlogenzym group vs four days (range 1-18; 95% CI--3.52 to 11.52) in the placebo group (p < 0.05); haemodynamic support was needed for two days (range 1-3; 95% CI--0.84 to 3.16) in the phlogenzym group but three days (range 1-8; 95% CI--0.76 to 5.24) in the placebo group (p < 0.05). The modified Glasgow coma scale score normalized in three days (range 1-14; 95% CI--4.62 to 9.62) in the phlogenzym group vs 5.5 days (range 1-18; 95% CI--2.52 to 13.52) in the placebo group (p > 0.05). Oral feeds could be started in four days (range 1-15; 95% CI--1.74 to 9.74) in the phlogenzym group vs five days (range 1-11; 95% CI--1.26 to 11.26) in the placebo group (p > 0.05). Two patients died in the placebo group.
Conclusion:
Phlogenzym is effective as an adjuvant with antibiotics and supportive treatment for early improvement of pediatric patients with sepsis.
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