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CandidiasisNCT00388167

Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection

An observational study of Candidiasis and Aspergillosis, run by PETHEMA Foundation at 27 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are refractory to or intolerant of other… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidiasis, Aspergillosis
What is being tested?
Caspofungin
Type of treatment
Injection or infusion
How many people
320 participants
Where
27 sitesSpain
Study dates
Mar 2004to Feb 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diagnosis of AI or CI

Who may be able to join

  • Female and male with 18 years old at least.
  • Diagnosis of AI or CI. It will be based in Clinical History, signs and symptoms that the patient takes, discovery of studies of radiology and results of cultivation and/or studies of anatomopathology positives for Candida spp. or Aspergillus spp.
  • Patients with AI, must be refractory to or intolerant of other therapies antifungal used in the hospital.
  • Patients with CI, must be or not refractory to or intolerant of other therapies antifungal used in the hospital.

Who cannot join

  • Patients with diagnosis uncertain based in one or more of next criterions: Cultivation positive for Candida in an only localization (urine, spittle, end/current of catheter; osteomyelitis or endocarditis by Candida without treatment appropriated surgical; infection by Candida of prosthetic material without retired of the same; positive blood cultive for Candida in appearance of vascular prosthesis; allergic lung Aspergillosis; and aspergilloma or aspergillosis eye without treatment appropriated surgical).
  • Allergic / hypersensitivity to caspofungin.
  • Insufficiency several liver (rate of Chile-Pugh >9).
  • Prediction of survival <5 days.
  • Pregnant or breast feeding.
  • Previous Participation of patient in this study.
  • Presence of other disease or any condition that it can mix up the interpretation of results or create risks.
  • Previous Participation of patient in other clinical study that it involve the administration of a drug in investigation in the 14 days previous to your inclusion in the study or during the administration of caspofungin. We can include patients took with antineoplastic drugs in research whenever at lefts a Investigator Coordinator authorizes it before

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Spain27 sites

  • Hospital Juan Canalejo

    A Coruña, La Coruña

  • Hospital General de Alicante

    Alicante, Alicante

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona

  • Hospital vall d'Hebrón

    Barcelona, Barcelona

  • Hospital Puerta del Mar

    Cadiz, Cádiz

  • Hospital general de Castellón

    Castelló, Castellón

  • Complejo Hospitalario Reina Sofía

    Córdoba, Córdoba

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada

  • Area Hospitalaria Juan Ramón Jimenez

    Huelva

  • Hospital general de Jerez de la Frontera

    Jerez de la Frontera

  • Institut Català d'Oncología

    L'Hospitalet de Llobregat, Barcelona

  • . Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga

  • Hospital Carlos Haya

    Málaga, Málaga

  • Xarxa assistencial de Manresa

    Manresa, Barcelona

  • Hospital Son Dureta

    Palma de Mallorca, Palma de Mallorca

  • Hospital Son Llàtzer

    Palma de Mallorca, Palma de Mallorca

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona, Tarragona

  • Hospital Verge de la Cinta

    Tortosa, Tarragona

  • Hospital Clínico de Valencia

    Valencia, Valencia

  • Hospital La Fe

    Valencia, Valencia

  • Hospital Universitario Dr. Peset

    Valencia, Valencia

  • Complejo Hospitalario Xeral-Cies

    Vigo, Vigo

Other trials in Spain

About this study

Official title: PROCAS: Study Observational Prospective and Multicenter to Determine the Clinic Effectiveness and the Safety of Caspofungin Acetate (CANCIDAS®) in the Treatment of Invader Fungal Infection

We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).

Read the detailed description

Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized

Being tested
Caspofungin
Keywords
Invader fungal infection (IFI), Invasive Aspergillosis (AI), Invasive Candidiasis (CI), Caspofungin acetate
Medical subject headings
Candidiasis, Aspergillosis, Candidiasis, Invasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaspofunginDrug

    The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment

Study groups in NCT00388167
Study groupRoleWhat they receive
1Caspofungin
Receives: Drug: Caspofungin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2006 (estimated)
  2. Study startMar 2004
  3. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388167
Sponsor's protocol ID
PET-CAS-2003-01
Other IDs
PET-CAS-2004-01
Status last verified
May 2009
First submitted
13 Oct 2006
Last updated
13 May 2009
Results posted
No

Publications

  • Keating GM, Jarvis B. Caspofungin. Drugs. 2001;61(8):1121-9; discussion 1130-1. doi: 10.2165/00003495-200161080-00007.

    PubMed 11465873

  • Tkacz JS. Glucan biosynthesis in fungi and its inhibition. In: Sutcliff JA, Georgopapadaku NH, eds. Emerging Targets in Antibacterial and Antifungal Chemotherapy. New York: Routledge, Chapman & Hall, 1992; 495-523.

  • Groll AH, Walsh TJ. Potential new antifungal agents. Curr Opin Infect Dis 1997; 10: 449-458

  • Debono M, Gordee RS. Antibiotics that inhibit fungal cell wall development. Annu Rev Microbiol. 1994;48:471-97. doi: 10.1146/annurev.mi.48.100194.002351.

    PubMed 7826015

  • Denning DW. Echinocandins and pneumocandins--a new antifungal class with a novel mode of action. J Antimicrob Chemother. 1997 Nov;40(5):611-4. doi: 10.1093/jac/40.5.611. No abstract available.

    PubMed 9421307

  • Arikan S, Lozano-Chiu M, Paetznick V, Rex JH. In vitro synergy of caspofungin and amphotericin B against Aspergillus and Fusarium spp. Antimicrob Agents Chemother. 2002 Jan;46(1):245-7. doi: 10.1128/AAC.46.1.245-247.2002.

    PubMed 11751145

  • Graybill JR, Najvar LK, Luther MF, Fothergill AW. Treatment of murine disseminated candidiasis with L-743,872. Antimicrob Agents Chemother. 1997 Aug;41(8):1775-7. doi: 10.1128/AAC.41.8.1775.

    PubMed 9257759

  • Espinel-Ingroff A. Comparison of In vitro activities of the new triazole SCH56592 and the echinocandins MK-0991 (L-743,872) and LY303366 against opportunistic filamentous and dimorphic fungi and yeasts. J Clin Microbiol. 1998 Oct;36(10):2950-6. doi: 10.1128/JCM.36.10.2950-2956.1998.

    PubMed 9738049

  • Bartizal K, Gill CJ, Abruzzo GK, Flattery AM, Kong L, Scott PM, Smith JG, Leighton CE, Bouffard A, Dropinski JF, Balkovec J. In vitro preclinical evaluation studies with the echinocandin antifungal MK-0991 (L-743,872). Antimicrob Agents Chemother. 1997 Nov;41(11):2326-32. doi: 10.1128/AAC.41.11.2326.

    PubMed 9371328

  • Kurtz MB, Heath IB, Marrinan J, Dreikorn S, Onishi J, Douglas C. Morphological effects of lipopeptides against Aspergillus fumigatus correlate with activities against (1,3)-beta-D-glucan synthase. Antimicrob Agents Chemother. 1994 Jul;38(7):1480-9. doi: 10.1128/AAC.38.7.1480.

    PubMed 7979276

  • Arikan S, Lozano-Chiu M, Paetznick V, Rex JH. In vitro susceptibility testing methods for caspofungin against Aspergillus and Fusarium isolates. Antimicrob Agents Chemother. 2001 Jan;45(1):327-30. doi: 10.1128/AAC.45.1.327-330.2001.

    PubMed 11120990

  • Bowman JC, Hicks PS, Kurtz MB, Rosen H, Schmatz DM, Liberator PA, Douglas CM. The antifungal echinocandin caspofungin acetate kills growing cells of Aspergillus fumigatus in vitro. Antimicrob Agents Chemother. 2002 Sep;46(9):3001-12. doi: 10.1128/AAC.46.9.3001-3012.2002.

    PubMed 12183260

  • Pfaller MA, Marco F, Messer SA, Jones RN. In vitro activity of two echinocandin derivatives, LY303366 and MK-0991 (L-743,792), against clinical isolates of Aspergillus, Fusarium, Rhizopus, and other filamentous fungi. Diagn Microbiol Infect Dis. 1998 Apr;30(4):251-5. doi: 10.1016/s0732-8893(97)00246-0.

    PubMed 9582584

  • Del Poeta M, Schell WA, Perfect JR. In vitro antifungal activity of pneumocandin L-743,872 against a variety of clinically important molds. Antimicrob Agents Chemother. 1997 Aug;41(8):1835-6. doi: 10.1128/AAC.41.8.1835.

    PubMed 9257774

  • Scott Hicks P, Dorso K, Gerckens I, et al. Comparative In Vitro Susceptibility of Clinical Trial Isolates to the Echinocandin Antifungal Caspofungin (Cancidas, MK- 0991) (Abstract: 193). 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto (Canada), 2000.

Questions about this trial

What is this clinical trial studying?

An observational study of Candidiasis and Aspergillosis, run by PETHEMA Foundation at 27 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388167, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2009.

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