Clinical Trials defination and phases, Pharmacovigilance of Levofloxacin Antibiotic Drug on Legionnaires Disease.

1. Dr. Babasaheb Ambedkar
Technology University
Shree Mahavir Education Society’s
Mahavir Institute of Pharmacy
PRACTICE SCHOOL

2. Course Structure and Contents for
PRACTICE SCHOOL (BP706PS)
B.Pharm Final Year (SEM VII)
DOMAIN – 18
PHARMACOVIGILANCE
PHARMACOVIGILANCE OF
LEVOFLOXACIN ON
LEGIONNAIRES DISEASE

3. A Review Article By:
Piyush Kiran Rodge
Final Year B.Pharmacy

4. Pharmacovigilance
of
Levofloxacin
on
Legionnaries Disease

5. Pharmacovigilance
• Pharmacovigilance is the
science of collecting,
monitoring, researching,
assessing and information
from healthcare providers and
patients on the adverse effects
of medications, biological
products and traditional
medicines.

6. Clinical Trials
Defination :-
“A type of research study
that test the drug or new
medicine before it comes to
the Market.”
 It is a life cycle of any product
how it comes to the market
after doing the various testing.
 Clinical Trials play an integral
role in the development of
new medical approaches.

7. Clinical Trial Process

8. Topic Contents
 Introduction
 Causes
 Symptoms
 Treatment
 Antibiotics which are used
 Conclusion

10. Legionnaires Disease
Introduction :
• First founded in American
legion in 1976.
• Then Joseph McDade, CDC
scientist who discovered the
cause of Legionnaires' disease
• This is mostly found in United
states of America and in
European countries.
• Spread through aerosolized
water particle.

11. What is Legionnaries Disease?
 It is respiratory disease instigated by the Legionella
species.
 Especially it is caused by gram negative bacteria name
as Legionella pneumophila.
 This disease is a type of pneumonia.
 This disease is mainly affected to our lungs.
 L. pneumophila is found in large bodies of water
including streams and lakes.

12.  The length of time between exposure and
symptom onset is two to 10 days but may
be up to 20.

13. Survival of Legionella according to the Temperature :-

14. Graphical representation of increasing Legionarries in US :-

15. Symptoms of Legionnaries
Disease:-
 Pain areas: In the chest or
muscles.
 Gastrointestinal: Diarrhoea,
Nausea or Vomiting.
 Whole body: Fever or Chills.
 Common Symptoms: Shortness
of breath, Coughing, Headache,
or Mental confusion.

16. Causes of Legionnaires
Hot tubs and whirlpools.
Cooling towers in air
conditioning systems.
Hot water tanks and
heaters.
Decorative fountains.
Swimming pools.
Drinking water.
Smoking may increase chances to cause Legionnaires.

17. Treatment for Legionnaires
Legionnaires' disease is treated with antibiotics.
There are three major classes of antibiotics that are
highly active in vitro against Legionella bacteria.
I. Fluoroquinolones (e.g. Levofloxacin, Moxifloxacin)
II. Macrolides (e.g. Erythromycin, Azithromycin)
III.Tetracyclines (e.g Doxycycline)
 The sooner therapy is started, the less likely the chance
of developing serious complications. In many cases,
treatment requires hospitalization.

18.  The minimum duration of therapy is 5 days for
patients.
 Patients with mild infection generally require 5 to 7
days of therapy.
 Patients with severe infection or chronic
comorbidities generally require 7 to 10 days of
therapy.
 Parenteral therapy is advised initially as the patient
may not tolerate antibiotics given by mouth
because of potential gastrointestinal symptoms.

19. Antibiotics which are used and there doses
 Levofloxacin 750 mg, one tablet for seven to ten
days.

20. Rifampin 300 to 600mg orally or
intravenously every 12 hours.
 Azithromycin, one followed by 500 mg
one tablet once a day for seven to 10 days.
 Erythromycin 1000mg intravenously every
6 hours, 500mg orally every 6 hours.
 Doxycycline 100mg orally or
intravenously every 12 hours.

21. Levofloxacin on Legionarries
 Levofloxacin is the group of
the Fluoroquinoles.
 Levaquin is a brand name of
Levofloxacin.
 Levofloxacin was more active
than Erythromycin and as
active as Ofloxacin or
Ciprofloxacin in this disease.

22.  Administering this drug may
lead to the higher risk in patient
above 60 year of age.
 The most common adverse
effect after administering are
Headache, Diarrhoe,
Constipation and Nausea.
 Some peoples may report
Abdominal Pain Dizziness,
Gases and difficulty in sleeping.

23.  One of the rare adverse effect is given in
below image is representing the damage to the
Aorta.
 Aneurysm is a swelling or ballooning in the
wall of the artery.

24. Conculsion
In conclusion while Legionella infection can
occur in both immunocompetent and immunocompromised
patients, certain risk factors in the immunocompromised
are associated with an increased incidence. T cell and cell
mediated immunity play a key role in body's defense
against the bacteria.
In our study Levofloxacin are used as
antibiotics, rather than some more antibiotics are used to
treat. More use of Levofloxacin may cause many adverse
effect (ADR) rarely it may cause serious adverse effect like
death of the person. In Phase IV (Post Marketing Phase) of
clinical research this adverse reaction are seen in some
peoples. To reduce this, further studies are done in
Pharmacovigilance of this disease.

25. THANK
YOU!!