LEVOFLOXACIN IV/ORAL VERSUS

CEFTRIAXONE IV/ CEFUROXIME

AXETIL ORAL THERAPY IN
ACUTE EXACERBATION OF
BRONCHIECTASIS
IN PERSAHABATAN HOSPITAL

Soepandi PZ, Mangunnegoro H, Widiatmoko A

Department of Respiratory Medicine, Faculty of Medicine,
University of Indonesia, Persahabatan Hospital, Jakarta
THE AIM OF STUDY

To Compare the Efficacy and Safety of

Levofloxacin Iv-oral With Ceftriaxone Iv-
Cefuroxime Axetil Oral in Acute Exacerbation of
Bronchiectasis Hospitalized
INCLUSION CRITERIA
.
1. Patients who were hospitalized
2. 18 – 70 years old
3. Willing to enroll the study
4. No antibiotic within 2 days
5. No of chronic GIT disturbance/
Malabsorption syndrome
6. No mental illness, alcoholism, dementia, drug
abuser, epilepsy
EXCLUSION CRITERIA

1. Allergic to the drug

2. Abnormal of liver/renal function
3. Severe comorbid
4. High risk patients (massive haemoptisis, sepsis)
5. Pregnant/breast feeding woman
DROP OUT FROM THE STUDY

1. AFB positive
2. Worsening in the first 2 days
3. Don’t want to continue the study
THE CRITERIA OF HOSPITALIZED
ACUTE EXACERBATION OF
BROCHIECTASIS WERE BASE ON :
A. Criteria of b.E :
1. History of chronic,productive cough
2. Chest x-ray finding: honey comb appearance
with/ without air fluid level, tubular pattern,
increasing of peribronchial pattern
3. Physical finding : crackles
B. THE CRITERIA OF ACUTE
EXACERBATION

• Increase the amount and gradation of sputum

• Increase of dyspnea
• Increase of cough
• Increase of body temperature
C. THE CRITERIA OF HOSPITALIZED

• Body temp. > 38 0c or <36 0c

• Resp.Rate >30 x/min
• Pulse rate >100 x/min
• Need oxygen
• Signs of shock
 MATERIALS AND METHODE

• Initial antibiotic were given i.V ( max. 5

days) and switch to oral (10 days)
 TABLE 1. MATERIAL AND METHOD
HAR I K E
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
VITAL SIGN + + + + + + + + +
SPUTUM + + + + + + + + +
WBC + + +

LFT + +

UREUM/CREAT + +

URINE +

AFB SPUTUM + + +

M.O SPUTUM + +

CHEST RONT. + +

SIDE EFFECT + + + + + + + + +

GIT FUNGTION + + + + + +
 THE CRITERIA OF SWITCH THERAPY
1. No clinical indication for continuing iv therapy
2. No abnormal GIT absorption
3. Patient a febrile for at least 8 h
4. Decrease of dyspnea (resp.rate < 24 x/min)
5. Pulse rate < 100 x/minute
6. Decrease the amount and gradation of sputum purulence
7. No disturbance of haemodynamic (systole >100 mmHg)
8. Take the drug orally
RESULTS :
 Graphic 1. Distribution of age
20
20
18
16
14 13
21-30
12 11
31-40
10 9 9
7 41-50
8
51-60
6 5 4
22 4 61-70
4 2
1 12
2
0
Levoflox Cetriax Total
Graphic 2. Distribution of sex

8 15 7 16

Male Female Male Female

Levoflox Cetftriax
TABLE 2. DISTRIBUTION OF COMORBID

GROUP
LEVOFLOX CEFTRIAX TOTAL
COMORBID

LIVER INSUF. 1 (4.35%) 3 (13.04%) 4 (8.70%)

CVD 1 (4.35%) 0 1 (2.17%)
RENAL INSUF. 0 1 (4.35%) 1 (2.17%)
CARDIAC DISS 2 (8.69%) 3 (13.04%) 5 (10.87%)
DM 2 (8.69%) 1 (4.35%) 3 (6.52%)
TABLE 3. DISTRIBUTION OF PREVIOUS
HOSPITALIZED FOR B.E

LEVOFLOX CEFTRIAX TOTAL

NEVER 8 (34.78%) 14 (60.87%) 22 (47.83%)

1 – 2 TIMES 11 (47.83%) 5 (21.74%) 16 (34.78%)

3 - 4 TIMES 1 (4.35%) 1 (4.35%) 2 (4.35%)

> 5 TIMES 3 (13.04%) 3 (13.04%) 6(13.04%)
Graphic 3. The mean of pulse
rate/minute
Levofloxacin
105.61
120 105.87 105.74 Ceftriaxone
100 89.83 88.36 89.10 Mean
89.15 83.78 86.47

80
60
40
20
0
0 day 3 days 14 days
Graphic 4. The mean of respiratory-rate
(times/minute)

35 Levofloxacin
30.96 30.74 30.85
30 Ceftriaxone
24.48 24.36 24.42
25 22.39 22.44 22.42 Mean
20
15
10
5
0
0 day 3 days 14 days
Graphic 5. The Mean of Body Temperature (o C)

37,6
37,4
37,2
37
36,8
36,6
36,4
36,2
36
35,8
0 day 3 days 14 days
Levofloxacin Ceftriaxone Mean
Graphic 6. The Mean of Sputum Production / 24
hours (CC)
45

30

15

0
0 day 3 days 14 days
Levofloxacin Ceftriaxone Mean
Graphic 7. The Mean of Purulence Sputum

6.83 6.61 6.72

6
5
4.96 4.98

1.78 1.78 1.78

2

0
0 day 3 days 14 days
Levofloxacin Ceftriaxone Mean
Graphic 8. The Mean of White Blood Cell Count

1,.330
15000 13.690
13,050

10,260 10,290 9,855

9,900 1,.080
10000 9,420

5000

0
0 day 3 days 14 days
Levofloxacin Ceftriaxone Mean
 Graphic 9. The Length of Switch Parenteral to Oral

12
11 11
10 Levo
Ceftri
8

6
4
4 3 3
3
2 1 1
0
3 days 4 days 5 days 6 days

Failure : Levo 5 (21.74%) Mean : Levo 4,11 days

Ceftri 4 (17.39%) Ceftri 4,47 days
 Graphic 10. The Length of Hospitalized
9
9
8 7
7 Levo
6 Ceftri
6
5
4
4 3 3
3 2
2
1 1 1
1 0 0 0 0 0 0
0
3 days 4 days 5 days 6 days 7 days 8 days 9 days > 10

Mean : Levo 4.66 days Total : Levo 18

Ceftri 5.78 days Ceftri 19
TABLE 4. THE CHEST X-RAY BEFORE AND
AFTER THERAPY

IMPROVE WORSEN STABIL CAN NOT

BE EVAL TOTAL

LEVOFLOXACIN 11 (61.1%) 1(5.6%) 6 (33.3%) 5(10.9%) 23

12 (66.7%) 2(11.1%) 4 (22.2%) 5(10.9%) 23

CEFTRIAXONE

TOTAL 23 (50.0%) 3 (6.5%) 10 (21.7%) 10(21.7%) 46

 TABLE 5. The Drug Related Adverse Events
LEVOFLOXACIN CEFTRIAXONE CEFUROXIME AXETIL
M MD M MD M MD

NAUSEA 2 (8.69%) 0 2 (8.69%) 1 (4.35%) 0 0

STOMATITIS/ 0 0
2 (8.69%) 0 2 (8.69%) 0
GLOSSITIS
0 0 2 (8.69%) 0 2 (8.69%) 0
CONSTIPATION
0 1 (4.35%)
RASH 0 0 0 1 (4.35%)

1 (4.35%) 0 0 1 (4.35%)
PALPITATION 1 (4.36%) 0
0 0
CEPHALGIA 0 1 (4.35%)
0 1 (4.35%)

Note : M : Mild
MD : Moderate
 TABLE 6. The Pattern of Microorganisms before
Therapy

PATHOGENS LEVOFLOX CEFTRIAXONE TOTAL

Gram negative 21 (75%) 17 (89.5%) 38 (80.9%)

- Klebsiella 9 (32.1%) 9 (47.4%) 18 (38.3%)
- P.aeruginosa 5 (17.9%) 4 (21.1%) 9 (19%)
- Acinetobacter 5 (17.9%) 3 (15.8%) 8 (17%)
- E.Coli 1 (3.6%) 1 (5.3%) 2 (4.3%)
- Enterobacter 1 (3.6%) 0 1 (2.1%)

Gram positive 7 (25%) 2 (10.5%) 9 (19.1%)

- Streptococcus Sp 5 (17.9%) 0 5 (10.6%)
- S.Aureus 2 (7.1%) 2 (10.5%) 4 (8.5%)
 TABLE 7. The Microbiologic Susceptibility Before
Therapy

Susceptibility Levofloxacin Ceftriaxone Cefuroxime

Sensitive 31 (65.96%) 23 (48.94%) 29 (61.70%)

Intermediate 4 (8.51%) 14 (29.79%) 6 (12.77%)

Resistant 12 (25.53%) 10 (21.28%) 12 (25.53%)

 TABLE 8. The Pattern of Microorganisms after
Therapy

PATHOGENS LEVOFLOX CEFTRIAXONE TOTAL

Gram negative 10 (58.82%) 15 (88.24%) 25 (73.53%)

- Klebsiella 5 (29.41%) 5 (29.41%) 10 (29.42%)
- P.aeruginosa 1 (5.88%) 6 (35.29%) 7 (20.59%)
- Acinetobacter 3 (17.65%) 4 (23.53%) 7 (20.59%)
- E.Coli 1 (5.88%) 0 1 (2.94%)
- Enterobacter 0 0 0

Gram positive 7 (41.12%) 2 (11.76%) 9 (26.47%)

- Streptococcus Sp 4 (23.53%) 1 (5.88%) 5 (14.71%)
- S.Aureus 3 (17.65%) 1 (5.88%) 4 (11.76%)

Total of Pathogen s 17 (50%) 17 (50%) 34 (100%)

 Table 9. The Proportion of Eradication Rate
Pathogen Levofloxacin, n=17 Ceftriaxone, n=12
Total Eradication rate Total Eradication rate

Negative Gram 16 12 (75.0%) 13 10(76.92%)

- Klebsiella 7 4 (57.14%) 7 6 (85.71%)
- Acinetobacter 4 4 (100%) 3 2 (66.67%)
- P.aeruginosa 3 2 (66.67%) 2 1 (50%)
- E.Coli 1 1 (100%) 1 1 (100%)
- Enterobacter 1 1 (100%) 0 0

Positive Gram 6 5 (83.33%) 3 3 (100%)

- Sterptococcus sp 4 3 (75%) 1 1 (100%)
- S.aureus 2 2 (100%) 2 2 (100%)

Total Pathogen 22 17 (77.27%) 16 13 (81.25%)

 Graphic 11. The Clinical Response

20
20
18
16
14
14
11
12 10
10
10
8 7 7
6 5
6
4
2 1 1
0
0
Levofloxacin Ceftriaxone Total

Clinical succes Improve Failure Not be eval

Graphic 12. Cost of Total Antibiotics/
patient 3 days iv and 10 days oral
2,000,000
1,800,000
1,600,000
1,400,000
1,200,000
1,000,000
800,000
600,000
400,000
200,000
0
iv Oral Total

Levo Cetriaf
Conclusion
• Levofloksasin and Ceftriaxone/cefuroxime
axetil have an equal efficacy
• Eradication rate not significant different
• Both therapies are save
• Levofloksasin has less side effect
• The cost of levofloksasin is more cheaper