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Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 1 Mortality.
Figures and Tables -
Analysis 1.1

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 1 Mortality.

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 2 Treatment failure.
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Analysis 1.2

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 2 Treatment failure.

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 3 Treatment failure ‐ per protocol analysis.
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Analysis 1.3

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 3 Treatment failure ‐ per protocol analysis.

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 4 Adverse events requiring discontinuation of antibiotics.
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Analysis 1.4

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 4 Adverse events requiring discontinuation of antibiotics.

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 5 Gastrointestinal adverse events ('post‐protocol' analysis).
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Analysis 1.5

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 5 Gastrointestinal adverse events ('post‐protocol' analysis).

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 6 Lost to follow‐up.
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Analysis 1.6

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 6 Lost to follow‐up.

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 7 Treatment failure not dt modification in update.
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Analysis 1.7

Comparison 1 Oral vs. intravenous antibiotic therapy, Outcome 7 Treatment failure not dt modification in update.

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 1 Treatment failure ‐ age.
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Analysis 2.1

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 1 Treatment failure ‐ age.

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 2 Treatment failure ‐ source of infection.
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Analysis 2.2

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 2 Treatment failure ‐ source of infection.

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 3 Treatment failure ‐ severity of neutropenia.
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Analysis 2.3

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 3 Treatment failure ‐ severity of neutropenia.

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 4 Treatment failure ‐ type of malignancy.
Figures and Tables -
Analysis 2.4

Comparison 2 Oral vs. intravenous antibiotic therapy ‐ subgroup analysis, Outcome 4 Treatment failure ‐ type of malignancy.

Comparison 3 Methodological quality of studies, Outcome 1 Allocation concealment.
Figures and Tables -
Analysis 3.1

Comparison 3 Methodological quality of studies, Outcome 1 Allocation concealment.

Comparison 4 Post‐hoc sub‐group analyses, Outcome 1 Setting.
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Analysis 4.1

Comparison 4 Post‐hoc sub‐group analyses, Outcome 1 Setting.

Comparison 4 Post‐hoc sub‐group analyses, Outcome 2 Type of oral antibiotics.
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Analysis 4.2

Comparison 4 Post‐hoc sub‐group analyses, Outcome 2 Type of oral antibiotics.

Table 1. Criteria of low risk patients (as defined in most included studies)

Common criteria

Haemodynamic stablity

No organ failure

Ability to take oral medications

No pneumonia

No infection of a central line

No severe soft‐tissue infection

No acute leukaemia as the background malignancy

No known drug allergy

Not pregnant or lactating women

Figures and Tables -
Table 1. Criteria of low risk patients (as defined in most included studies)
Table 2. Reasons for Exclusion

Study ID

Evident infection

Previous AB

Prolonged neutropeni

Performance status

Active malignancy

BMT/PSCT

Other

Kern 1999

Infected catheter or CNS infection, known bacterial /viral/fungal infection

yes

yes

no

no

yes

Need of IV supportive therapy, expected to die within 48 hours, HIV, fever unrelated to infection and protocol violation

Mullen 1999

A source of infection that required hospitalisation as: tunnelitis, pneumonia, perirectal cellulitis, typhlitis, resistant microorganism to one of the study's drugs

no

no

no

yes

yes

>10% dehydration, bleeding requiring platelet transfusion,
need for IV access, no access to telephone, >1hour away from hospital unreliable caretaker

Paganini 2000

Infected catheter, perineal/ facial cellulitis, uncontrolled local infection, positive blood cultures at 72 hours

no

no

no

yes

yes

Persistance of fever >48 hours, incorrectable bleeding; refractory hypoglycemia or hypocalcemia

Rubenstein 1993

Known resistant microorganism

no

no

no

no

no

Na<128, uncontrolled hypercalcemia, more than 30 miles away

Samonis 1997

Pneumonia, deep organ infection

yes

yes

no

yes

no*

Prior hospitalisation

Shenep 2001

Pneumonia, clinical or radiographic evidence of focal bacterial infection, severe mucositis, positive blood cultures at 48 hours

no

no

no

no

no

MRSA or P.Aeroginosa in any culture obtained in preceding 12weeks

Velasco1995

Meningitis, pyelonephritis

yes

no

yes

no

no*

Long term central vein catheter

Petrilli 1999

no

no

no

no

no

no*

Flaherty 1989

no

yes

no

no

no

no

Freifeld 1999

Intravascular infection, tunnelitis, pneumonia, neurologic symtoms,

no

yes

no

no

yes

Treatment with Ca‐Mg or probenecid or alluporinol or theophylline, HIV

Giamarelou 2000

Suspected anaerobes

no

no

yes

no

no

Moribund and high probability of dying within 48 hours

Hidalgo 1999

Pneumonia, extensive cellulitis, meningitis, pyelonephritis

no

no

yes

yes

no

Clotting abnormalities, acidosis, hypercalcemia, uncontrolled bleeding, live >2h apart from hospital; Hx of tumor fever, other severe extra hematologic chemotherapy induced toxicity, no 24 hours home companion

Innes 2003

Tunnelitis, cellulitis, abcess, clinically documented infection likely to require prolonged antibiotic therapy

yes

yes

no

no

yes

Need for the use of G/GM‐CSF and cytokines; no responsible adult living with them (carer);

Malik 1992

no

yes

no

no

no

no

Recurrent FUO

Cornely 2003

not excluded

excluded (except cotrimoxazole prophylaxis)

yes

yes

excluded

excluded

potential compromised absorption; inability to take oral medication; tenopathy, epilepsy; aplastic anemia, acute leukemia; septic shock or signs of sever infection; HIV carrier; serious concomitant disease, liver transaminase> x5 of norm.

Niho 2004

not excluded

excluded

no

not excluded

no

yes

Recurrent FUO; renal insufficiency; hepatic insufficiency; hypotension or peripheral circulatory failure; uncontrolled hypercalcemia; altered sensorium; respiratory rate >30 breaths/min; serum sodium <128 mg/dl; inability to take oral medications; intestinal malabsorption

Paganini 2003

Fascial, perineal, or catheter‐associated cellulites; uncontrolled local infection; positive blood cultures within the first 48 hours; infection with microorganisms known as resistant to ceftriaxone or ciprofloxacin

included

yes

not excluded

not excluded

excluded

severe comorbidity factors; respiratory ffailure

Figures and Tables -
Table 2. Reasons for Exclusion
Comparison 1. Oral vs. intravenous antibiotic therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

9

1392

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.54, 1.68]

1.1 Initially oral

6

961

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.43, 1.62]

1.2 Sequential

3

431

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.45, 4.22]

2 Treatment failure Show forest plot

18

2763

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.85, 1.07]

2.1 Initially oral treatment

12

1817

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.77, 1.03]

2.2 Sequential IV to oral treatment

6

946

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.90, 1.27]

3 Treatment failure ‐ per protocol analysis Show forest plot

18

2547

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.86, 1.13]

3.1 Initially oral treatment

12

1626

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.75, 1.11]

3.2 Sequential IV to oral treatment

6

921

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.88, 1.29]

4 Adverse events requiring discontinuation of antibiotics Show forest plot

12

1577

Risk Ratio (M‐H, Random, 95% CI)

1.80 [0.58, 5.60]

4.1 Initially oral treatment

7

818

Risk Ratio (M‐H, Random, 95% CI)

5.76 [1.68, 19.73]

4.2 Sequential IV to oral treatment

5

759

Risk Ratio (M‐H, Random, 95% CI)

0.57 [0.26, 1.25]

5 Gastrointestinal adverse events ('post‐protocol' analysis) Show forest plot

13

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Initially oral treatment

9

1216

Risk Ratio (M‐H, Fixed, 95% CI)

5.14 [3.15, 8.38]

5.2 Sequential IV to oral treatment

4

784

Risk Ratio (M‐H, Fixed, 95% CI)

2.81 [1.03, 7.66]

6 Lost to follow‐up Show forest plot

15

2432

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.61, 1.11]

7 Treatment failure not dt modification in update Show forest plot

18

2763

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.85, 1.06]

7.1 Initially oral treatment

12

1817

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.77, 1.04]

7.2 Sequential IV to oral treatment

6

946

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.88, 1.25]

Figures and Tables -
Comparison 1. Oral vs. intravenous antibiotic therapy
Comparison 2. Oral vs. intravenous antibiotic therapy ‐ subgroup analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Treatment failure ‐ age Show forest plot

16

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Children

5

742

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.77, 1.33]

1.2 Adults

11

1558

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.86, 1.14]

2 Treatment failure ‐ source of infection Show forest plot

10

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Unexplained fever

10

924

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.79, 1.33]

2.2 Documented infection

10

641

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.84, 1.19]

3 Treatment failure ‐ severity of neutropenia Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Absolute neutrophil count >=10^9/L

3

328

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.45, 0.98]

3.2 Absolute neutrophil count <10^9/L

3

370

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.76, 1.49]

4 Treatment failure ‐ type of malignancy Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Solid tumour

6

899

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.63, 1.10]

4.2 Haemetologic malignancy

4

412

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.84, 1.28]

Figures and Tables -
Comparison 2. Oral vs. intravenous antibiotic therapy ‐ subgroup analysis
Comparison 3. Methodological quality of studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Allocation concealment Show forest plot

18

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Adequate (A)

9

1405

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.79, 1.11]

1.2 Unclear (B)

9

1358

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.83, 1.13]

Figures and Tables -
Comparison 3. Methodological quality of studies
Comparison 4. Post‐hoc sub‐group analyses

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Setting Show forest plot

14

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Oral‐outpatient, IV‐inpatients

3

430

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.63, 1.43]

1.2 Inpatients

5

1037

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.79, 1.05]

1.3 Outpatients

6

697

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [0.83, 1.49]

2 Type of oral antibiotics Show forest plot

18

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Quinolones only

7

967

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.88, 1.20]

2.2 Quinolones in combination with augmentin, ampicillin‐sulbactam, penicillin V or clindamycin

8

1408

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.72, 1.03]

2.3 Cefixime

2

354

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.64, 1.56]

2.4 New quinolones

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.42, 9.50]

Figures and Tables -
Comparison 4. Post‐hoc sub‐group analyses