Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

Liat Vidal; Itsik Ben dor; Mical Paul; Ellisheva Pokroy; Karla Soares‐Weiser; Leonard Leibovici

doi:10.1002/14651858.CD003992.pub2

Scolaris Content Display Scolaris Content Display

Contenido relacionado

Ir a:

Revisiones y protocolos relacionados
Guías
Temas

Revisiones y protocolos relacionados

Topics

Temas

Analysis 1.1

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.2

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.3

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.4

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.5

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.6

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.7

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.1

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.2

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.3

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.4

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.1

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.1

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.2

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

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

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

Ir a la tabla de la revisión

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

Table 2. Reasons for Exclusion

Ir a la tabla de la revisión

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]

Comparison 1. Oral vs. intravenous antibiotic therapy

Ir a la tabla de la revisión

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]

Comparison 2. Oral vs. intravenous antibiotic therapy ‐ subgroup analysis

Ir a la tabla de la revisión

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]

Comparison 3. Methodological quality of studies

Ir a la tabla de la revisión

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]

Comparison 4. Post‐hoc sub‐group analyses

Ir a la tabla de la revisión

The Cochrane Library

Scolaris Language Selector Scolaris Language Selector

Idioma de la Revisión Cochrane

Idioma de la web

Scolaris Content Language Banner Portlet Scolaris Content Language Banner Portlet