Daptomycin Versus Placebo in Patients With Neutropenia and Fever

To determine whether the percentage of neutropenic subjects that become afebrile by five
days after fever first develops is higher when daptomycin compared to placebo is added at
the same time as anti gram-negative therapy. The five day time point is selected because it
is at this point where it is recommended to add antifungal therapy to the treatment regimen
if the patient is still febrile.

Inclusion Criteria:

1. Patients in the above categories who are currently undergoing chemotherapy.

2. Patients at least 18 of age.

3. Patient expected to reach an absolute granulocyte count of <100 cells/mm3

4. Patients who have given written consent because of the above criteria must have at
least one temperature of greater or equal to 38.3° or temperatures > 38o on at least
two occasions before study drug is administered.

Exclusion Criteria:

1. Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their
neutropenia is of insufficient duration for adequate test of the value of an
anti-gram positive antibiotic.

2. Patients undergoing auto-transplantation, for the same reason as above.

3. Patients with evidence of a clinical infection such as presence of a pulmonary
infiltrate by x-ray or clinical evidence for the presence of cellulitis.

4. Patients who have received daptomycin in the two weeks prior to enrollment.

5. Patients with concomitant use of vancomycin.

6. Patients with creatinine clearance < 30 ml/min or CPK > 3x normal

7. Patients with significant hepatic dysfunction, defined as baseline liver function
tests > 5x above normal.

8. Patients with known allergy to daptomycin.

9. Patients previously in this study.

10. Women of child bearing age who are either lactating or pregnant (as evidenced by a
positive urine pregnancy test or positive serum beta-HCG).

11. Patients previously enrolled in this study.