Key clinical-trial evidence for posaconazole

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, April 2015.

Posaconazole (NOXAFIL®) is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older:

Posaconazole is also indicated for the:

Clinical studies

Prophylaxis of aspergillus and candida infections with posaconazole oral suspension

Table 1
Study Posaconazole Controla P value
Proportion (%) of patients with proven/probable IFIs – no./total no. patients (%)
On treatment period*
Study 1 7/291 (2) 22/288 (8) 0.0038
Study 2 7/304 (2); 25/298 (8) 0.0009
Fixed time period**
Study 1 7/301 (2) 21/299 (7) < 0.0059
Study 2 4 /304 (1); 26 /298 (9) < 0.0001

* In study 2 this was the period from randomization to last dose of study medication plus 7 days; in study 1 it was the period from first dose to last dose of study medication plus 7 days.

**In study 2, this was the period from randomization to 100 days post-randomization; in study 1 it was the period from the Baseline day to 111 days post-baseline. a ); fluconazole (study1); Fluconazole/itraconazole (study 2)

Treatment of azole-susceptible oropharyngeal candidiasis

Table 2
End point Posaconazole Fluconazole
Clinical success rate at Day 14 91.7 % (155/169) 92.5 % (148/160)
Clinical success ratea 4 weeks after end of treatment 68.5 % (98/143) 61.8 % (84/136)
Mycological response rateb 4 weeks after end of treatment** 40.6 % (41/101) 26.4 % (24/91)

a Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.

b Mycological response rate was defined as mycological success (≤ 20 CFU/ml) divided by the total number of cases eligible for analysis.

** p = 0.04

Treatment of azole-refractory oropharyngeal candidiasis

Treatment of invasive aspergillosis

Table 3
End point Posaconazole External control group
Overall response 45/107 (42%) 22/86 (26%)
Survival at day 365 38% 22% [P= 0.006]
Success by species
Aspergillus fumigatus 12/29 (41 %) 12/34 (35 %)
Aspergillus flavus 10/19 (53 %) 3/16 (19 %)
Aspergillus tereus 4/14 (29 %) 2/13 (15 %)
Aspergillus niger 3/5 (60 %) 2/7 (29 %)

Treatment of coccidioidomycosis

Place of posaconazole in fungal infections

Related information

Make a donation

Donate Today

Help us to update and maintain DermNet New Zealand

Submit your images

We are expanding our image library

Contact us

Skin lesion photography

Watch Dr Amanda Oakley presenting "Skin lesion photography" at The Australasian Skin Cancer Congress.

Subscribe to our mailing list

* indicates required
DermNet NZ Newsletter