NCT00002850 · OUTCOME

Proportion of Patients Experiencing a Serious Bacterial Infection

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy · Source last updated 2015-11-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: First three months of chemotherapy

What was measured

This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.

Groups in this outcome

Ciprofloxacin or Ofloxacin

ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.

TMP-SMX

trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..

No Prophylaxis

The patient will receive no prophylactic antibiotics.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Ciprofloxacin or Ofloxacin	64
TMP-SMX	74
No Prophylaxis	63

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ciprofloxacin or Ofloxacin	12.5	Not reported	5.6	23.2	Not reported
TMP-SMX	6.8	Not reported	2.2	15.1	Not reported
No Prophylaxis	15.9	Not reported	7.9	27.3	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Description
H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level. Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.218
statistical Comment
Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.
statistical Method
Fisher Exact
tested Non Inferiority
false

Complete source fields

analyses

group Description
H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level. Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.218
statistical Comment
Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.
statistical Method
Fisher Exact
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
5.6
upper Limit
23.2
value
12.5
group Id
OG001
lower Limit
2.2
upper Limit
15.1
value
6.8
group Id
OG002
lower Limit
7.9
upper Limit
27.3
value
15.9

denoms

counts
group Id
OG000
value
64
group Id
OG001
value
74
group Id
OG002
value
63
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
id
OG000
title
Ciprofloxacin or Ofloxacin
description
trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..
id
OG001
title
TMP-SMX
description
The patient will receive no prophylactic antibiotics.
id
OG002
title
No Prophylaxis

param Type

NUMBER

reporting Status

POSTED

time Frame

First three months of chemotherapy

title

Proportion of Patients Experiencing a Serious Bacterial Infection

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice