{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T04:24:10Z","timestamp":1768451050459,"version":"3.49.0"},"reference-count":18,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2000,7,1]],"date-time":"2000-07-01T00:00:00Z","timestamp":962409600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2000,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Systemic and superficial fungal infections are a major problem among immunocompromised patients with hematological malignancy. A double-blind, double-placebo, randomized, multicenter trial was performed to compare the efficacy and safety of itraconazole oral solution (2.5 mg\/kg of body weight twice a day) with amphotericin B capsules (500 mg orally four times a day) for prophylaxis of systemic and superficial fungal infection. Prophylactic treatment was initiated on the first day of chemotherapy and was continued until the end of the neutropenic period (&gt;0.5 \u00d7 10<jats:sup>9<\/jats:sup>neutrophils\/liter) or up to a maximum of 3 days following the end of neutropenia, unless a systemic fungal infection was documented or suspected. The maximum treatment duration was 56 days. In the intent-to-treat population, invasive aspergillosis was noted in 5 (1.8%) of the 281 patients assigned to itraconazole oral solution and in 9 (3.3%) of the 276 patients assigned to oral amphotericin B; of these, 1 and 4 patients died, respectively. Proven systemic fungal infection (including invasive aspergillosis) occurred in 8 patients (2.8%) who received itraconazole, compared with 13 (4.7%) who received oral amphotericin B. Itraconazole significantly reduced the incidence of superficial fungal infections as compared to oral amphotericin B (2 [1%] versus 13 [5%];<jats:italic>P<\/jats:italic>= 0.004). Although the incidences of suspected fungal infection (including fever of unknown origin) were not different between the groups, fewer patients were administered intravenous systemic antifungals (mainly intravenous amphotericin B) in the group receiving itraconazole than in the group receiving oral amphotericin B (114 [41%] versus 132 [48%];<jats:italic>P<\/jats:italic>= 0.066). Adequate plasma itraconazole levels were achieved in about 80% of the patients from 1 week after the start of treatment. In both groups, the trial medication was safe and well tolerated. Prophylactic administration of itraconazole oral solution significantly reduces superficial fungal infection in patients with hematological malignancies and neutropenia. The incidence of proven systemic fungal infections, the number of deaths due to deep fungal infections, and the use of systemic antifungals tended to be lower in the itraconazole-treated group than in the amphotericin B-treated group, without statistical significance. Itraconazole oral solution is a broad-spectrum systemic antifungal agent with prophylactic activity in neutropenic patients, especially for those at high risk of prolonged neutropenia.<\/jats:p>","DOI":"10.1128\/aac.44.7.1887-1893.2000","type":"journal-article","created":{"date-parts":[[2002,7,27]],"date-time":"2002-07-27T05:56:57Z","timestamp":1027749417000},"page":"1887-1893","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":118,"title":["Itraconazole Oral Solution for Primary Prophylaxis of Fungal Infections in Patients with Hematological Malignancy and Profound Neutropenia: a Randomized, Double-Blind, Double-Placebo, Multicenter Trial Comparing Itraconazole and Amphotericin B"],"prefix":"10.1128","volume":"44","author":[{"given":"J. L.","family":"Harousseau","sequence":"first","affiliation":[{"name":"<!--label omitted: 1-->Ho\u0302pital Dieu, Nantes,1 and"}]},{"given":"A. W.","family":"Dekker","sequence":"additional","affiliation":[{"name":"<!--label omitted: 2-->University Hospital, Utrecht, The Netherlands2;"}]},{"given":"A.","family":"Stamatoullas-Bastard","sequence":"additional","affiliation":[{"name":"<!--label omitted: 3-->Centre Henri Becquerel, Rouen,3 France;"}]},{"given":"A.","family":"Fassas","sequence":"additional","affiliation":[{"name":"<!--label omitted: 4-->George Papanikolaou General Hospital, Thessalonika, Greece4;"}]},{"given":"W.","family":"Linkesch","sequence":"additional","affiliation":[{"name":"<!--label omitted: 5-->Medizinische Universita\u0308tsklinik, Graz, Austria5;"}]},{"given":"J.","family":"Gouveia","sequence":"additional","affiliation":[{"name":"<!--label omitted: 6-->Hospital Dos Capuchos, Lisbon, Portugal6;"}]},{"given":"R.","family":"De Bock","sequence":"additional","affiliation":[{"name":"<!--label omitted: 7-->Algemeen Ziekenhuis Middelheim, Antwerp,7 and"}]},{"given":"M.","family":"Rovira","sequence":"additional","affiliation":[{"name":"<!--label omitted: 8-->Hospital Cl\u0131\u0301nic IDIBAPS, Barcelona, Spain8"}]},{"given":"W. F.","family":"Seifert","sequence":"additional","affiliation":[{"name":"<!--label omitted: 9-->Janssen Research Foundation, Beerse,9Belgium; and"}]},{"given":"H.","family":"Joosen","sequence":"additional","affiliation":[{"name":"<!--label omitted: 9-->Janssen Research Foundation, Beerse,9Belgium; and"}]},{"given":"M.","family":"Peeters","sequence":"additional","affiliation":[{"name":"<!--label omitted: 9-->Janssen Research Foundation, Beerse,9Belgium; and"}]},{"given":"K.","family":"De Beule","sequence":"additional","affiliation":[{"name":"<!--label omitted: 9-->Janssen Research Foundation, Beerse,9Belgium; and"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"crossref","first-page":"S43","DOI":"10.1093\/clinids\/14.Supplement_1.S43","article-title":"Opportunistic mycoses in the immunocompromised host: experience at a cancer center and review.","volume":"14","author":"Anaissie E.","year":"1992","unstructured":"Anaissie E. Opportunistic mycoses in the immunocompromised host: experience at a cancer center and review. Clin. Infect. Dis. 14 (Suppl.1) 1992 S43 S53","journal-title":"Clin. Infect. Dis."},{"key":"e_1_3_2_3_2","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1016\/0924-8579(95)00043-7","article-title":"Itraconazole: pharmacology, clinical experience and future development.","volume":"6","author":"De Beule K. L.","year":"1996","unstructured":"De Beule K. L. Itraconazole: pharmacology, clinical experience and future development. Int. J. Antimicrob. Agents Chemother. 6 1996 175 181","journal-title":"Int. J. Antimicrob. Agents Chemother."},{"key":"e_1_3_2_4_2","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/0002-9343(94)90023-X","article-title":"NIAID mycoses study group multicenter trial of oral itraconazole therapy of invasive aspergillosis.","volume":"97","author":"Denning D. W.","year":"1994","unstructured":"Denning D. W. Lee J. Y. Hostetler J. S. Pappas P. Kauffman C. 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