Revisions for Homeostec for the treatment of chronic Chikungunya | Registro Público Cubano de Ensayos Clínicos

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--- 27 December 2016 - 4:12pm by Gladys
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Revision of 6 May 2018 - 12:31pm:

Homeostec for the treatment of chronic Chikungunya

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

CHIKCRONTX

Scientific title:

Toxicity of the intravenous application of Homeostec in patients with chronic manifestations of Chikungunya virus infection: Clinical Trial Phase I.

Acronym of Scientific Title:

CHIKCRONTX

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Colima State Health Service (SSA-COLIMA), Mexico ESTERIPHARMA Foundation for Ethics, Education and Research for the Cancer of the Cancerology State Institute A.C.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rodrigo

Last name:

Lopez Flores

Medical Specialty :

Family Phisician

Affiliation:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima)

Postal address:

Avenue "Liceo de Varones" 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

+52-3123162740 ext. 686

+52-3121521435

Email address:

rodrigo_888@hotmail.com

ivan_delgado_enciso@ucol.mx

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), September 9th, 2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

10/01/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic Joint Disease Caused by Chikungunya Virus

Health condition(s) code:

Chikungunya Fever

Arthritis, Infectious

Arthritis

Joint Diseases

Musculoskeletal Diseases

Infection

Intervention(s):

Group I (experimental): Homeostec (5 ml) + Paracetamol (500 mg). The patient will receive 5 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 20 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness. Group II (experimental): Homeostec (10 ml) + Paracetamol (500 mg)). The patient will receive 10 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 40 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness. Group III (experimental): Homeostec (20 ml) + Paracetamol (500 mg)). The patient will receive 20 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 80 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness. Group IV (Control): Paracetamol (500 mg). The patients will receive 500mg of Paracetamol every 8 hours by oral route if they have pain and, they will be managed by your family physician.

Intervention code:

Solutions

Acetaminophen

Administration, Intravenous

Infusions, Intravenous

Administration, Oral

Tablets

Intervention keyword:

Homeostec, Solución electrolizada, Paracetamol

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse Events (Present, Absent. Adverse Events will be measured according to the Common Terminology Criteria for Adverse Events V3.0 (CTCAE). During the application of HOMEOSTEC the patient will have a cardiac monitor during 6 hours. Blood tests (pH, blood count, serum electrolytes, bleeding tests, and blood chemistry), physical examination and interrogation will be performed). Measuring time: at baseline, at 15 and 60 minutes, at 6, 24, 48 and 72 hours, at 15 and 30 days.

Key secondary outcomes:

Joint pain (analogue-numeric scale of pain). Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days. Progression of joint disease (Routine Assessment of Patient Index Data-RAPID 3, >12 = High; between 6.1 and 12 Moderate; between 3.1 and 6 low; between 0 and 3 remission): Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients with confirmed diagnosis of Chikungunya virus infection by RT-PCR or ELISA (IgG and / or IgM anti-Chikungunya) in the previous months. 2. Age: 18 years and older. 3. Persistent musculoskeletal pain or arthritis for more than 4 weeks after onset of Chikungunya virus infection. 4. Suffering musculoskeletal or joint pain maximum on analogue-visual scale of 4 or more in the last 24 hours 5. Acceptance in writing, previous information. 6. Negative urine pregnancy test.

Exclusion criteria:

1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Symptomatic osteoarthritis prior to infection. 4. Decompensated systemic disease. 5. Creatinine 1.25 times greater than normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 6. Leukocytes equal to or less than 3000 cells / μL or platelet count less than 100,000 cells / μl. 7. Blood hemoglobin less than 10g / dL. 8. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or appearance of hematuria or proteinuria greater than 300 milligrams / day. 9. Pseudo intestinal obstruction. Defined as abdominal pain, with airway levels on AP and lateral lateral views of the abdomen. 10. Pregnant women or women of childbearing potential without a contraceptive method: salpingoclasia, device or hormonal, or Breastfeeding women. 11. Alcoholism and/or drug addiction. 12. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 13. Presence of: Cancer. 14. Other pathologies at the discretion of the researcher.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Other

Other design:

Dose-Escalation study

Phase:

1

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivan

Last Name:

Delgado Enciso

Specialty:

General medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

52 3121521435

Email :

ivancoliman@hotmail.com

ivan_delgado_enciso@ucol.mx

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ivan

Last Name:

Delgado Enciso

Specialty:

General medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

52 3121521435

Email :

ivancoliman@hotmail.com

ivan_delgado_enciso@ucol.mx

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000226

Date of Registration in Primary Registry:

27/12/2016

Record Verification Date:

2017/01/18

Next update date:

2018/01/18

Link to the spanish version:

Click here

Registered Trials

Registration process

Homeostec for the treatment of chronic Chikungunya

About the RPCEC

Useful resources