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A Randomized, Placebo-Controlled Phase I/IIa Study to Evaluate the Safety, Tolerability, and Efficacy of PG04 Ointment in Subjects Colonized with Staphylococcus aureus

PHRR210610-003324

UPMREB CODE: 2019-309-01

2020-CT0525

A Randomized, Placebo-Controlled Phase I/IIa Study to Evaluate the Safety, Tolerability, and Efficacy of Psidium guajava Ointment in Subjects Colonized with Staphylococcus aureus

This is a Phase 1/2a study, randomized, double-blinded placebo controlled trial, using 3 doses of guava, to evaluate the efficacy, safety, and tolerability of the guava topical ointment in the eradication of nasal carriage of S. aureus in healthy volunteers aged 19 to 55 years old. This study design has been used previously in other antibacterial agents used for the eradication of nasal Staphylococcus aureus. 3 dose are used since this is still a dose finding study to learn lowest dose which may effectively eradicate MSSA. Also monitoring for adverse effects, both signs and symptoms as well as blood chemistry, x-ray and ECG, is an integral part of this study.

Because of the morbidity, mortality, and complications brought about by the bacterial skin and mucosal diseases, the search for new therapies is necessary. Numerous researches have looked into the potential of guava leaf extracts and have found it to be a potent antibacterial agent. Our own in vitro and in vivo researches have shown the great potential of guava to eradicate gram-positive bacteria, even Methicillin-resistant Staphylococcus aureus, which is a big threat to our health. This Phase I/IIa clinical study will investigate the safety and initial clinical efficacy in the eradication of nasal carriage of Staphylococcus aureus in otherwise healthy adult volunteers. If results are favorable, this study will pave the way to further clinical testing (Phase 2b and 3 clinical trials) in patients with localized bacterial skin infections such as impetigo, and an essential element in the eventual registration as herbal medicine. Providing a low cost, locally produced herbal bacterial ointment will be a great boost to the local pharmaceutical companies willing to manufacture it as well as the Filipino patients in need of a safe and efficacious and low-cost antibacterial ointment. Also, Psidium guajava may be a new high-value cash crop for our farmers. Thus, so many stakeholders shall be greatly benefitted.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Biomedical products and engineering
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-01-10 18 2021-07-10 2021-07-10

Completed

Institution Classification Region LTO #
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine Government NCR 3000001863742
Institution Classification Region LTO #
University of the Philippines - Manila, College of Medicine Public Higher Education Institution - State Universities and Colleges NCR
Institution Region
Philippine Institute of Traditional and Alternative Health Care NCR
Name E-Mail Institution and Institution Address
Cecilia C. Maramba ccmaramba@up.edu.ph Institute of Herbal Medicine, NIH, UP Manila
Name E-Mail Institution and Institution Address
Cecilia C. Maramba ccmaramba@up.edu.ph Institute of Herbal Medicine, NIH, UP Manila
Name Expertise Affiliation
Cecilia Nelia C. Maramba-Lazarte, MD Pediatric Infectious Diseases, Pharmacology, Herbal Medicine National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Essel N. Tolosa Formulation National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Jaime M. Purificacion Family Medicine National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Johannes Paolo B. Cerrado, MD Internal Medicine National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Ruth . Elio Nurse/Clinical monitor National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Project Location Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A

Individuals with sift tissue, mucosal or skin colonization or infection with S. Aureus.


a) To determine the percentage eradication of nasal carriage of S. aureus of 15%, 30%, and 50% Psidium guajava ointment applied topically.
b) To determine the adverse effects and the percent of participants who developed adverse effects to the different concentrations of topically applied Psidium guajava ointment.
c) To determine the percentage of recurrence of positive S. aureus cultures from the nasal mucosa 7 days post-treatment.

a. acceptability and tolerability of different doses of guava ointment

b. nasal symptom score

Recruiting

  • Philippines

Clinical Trial

UPMREB CODE: 2019-309-01

20 191118130939

2020-06-10

0000-00-00

40

Unspecified

Unspecified

2020-01-10

Inclusion Criteria

1. Healthy male or female, as determined by a responsible and experienced physician. If female, the subject should be of non-childbearing potential (physiologically incapable of becoming pregnant, including pre-menopausal females with documented hysterectomy or double oophorectomy or documented tubal ligation; or post-menopausal females defined as being amenorrheic for greater than one year), otherwise, should agree to use one of the contraception methods from screening up to the follow-up examination. Methods include nonhormone contraception such as IUD or diaphragm, abstaining from sexual intercourse.
2. Age between 19 and 55 years based on a government-issued ID with their birthday.
3. Non-smoker (defined as never smoked or not smoking for >6 months prior to Day 1 with 4. Body Mass Index (BMI) within the range >18.5 < 25.0 kg/m2 at screening
5. No clinically important abnormal physical findings at the screening examination.
6. Normal or clinically acceptable complete blood count, random blood sugar, blood urea nitrogen, creatinine, sodium, potassium, AST, ALT, uric acid, urinalysis, fecalysis with occult blood, chest X-ray and ECG.
7. Normal blood pressure (systolic: 90-119 mmHg; diastolic: 50-79 mmHg) and heart rate (40-100 bpm).
8. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
9. Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
B. Exclusion Criteria
1. Pregnancy as determined by positive urine hCG test at screening or prior to dosing (for those with child-bearing potential) (Day 1).
2. Lactating females.
3. Nasal surgery in the previous 3 months.
4. Evidence of active rhinitis, sinusitis, or upper respiratory infection.
5. Negative nasal culture for S. aureus on the first screen visit.
6. Negative nasal culture for S. aureus on both the second and third screen visits.
7. Concurrent treatment with antimicrobials for an infection.
8. MRSA decolonization attempt in the previous 6 months (prior treatment for an MRSA infection is not an exclusion criterion).
9. Inability to take medications nasally

Interventional

Guava ointment

  • A 30% and 50% guava ointment has been formulated from fresh, young guava leaves.
  • PEG 4000 and PEG 400 were excipients used.

None

Randomized

Double Blind

The pharmacist will prepare the 3 doses of guava topical ointment and placebo. Each container of guava topical ointment and placebo ointment will be labeled with an accession number. Only the pharmacist and researchers know the designation of each dose or placebo. The guava topical ointment will be randomly assigned to the participants. The guava topical ointment will be then handed over to one member of the research staff for distribution to the participants. The subjects will not be informed of which specific group they belong to. The statistician, the physician who will evaluate each participant, and the research staff who will distribute the ointment will all be blinded as well.

Parallel

To assess the efficacy, safety, and tolerability of 15%, 30% and 50% concentrations of guava (Psidium guajava) ointment in healthy adults aged 19 to 55 years old who are colonized with S. aureus.

Phase I/II

Utilization Utilization Info
Publication
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