Evaluation of photodynamic therapy (a treatment that involves light-sensitive medicine and a light source to destroy abnormal cells) as a safe and effective treatment for malaria
| ISRCTN | ISRCTN80135736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80135736 |
- Submission date
- 05/09/2022
- Registration date
- 06/09/2022
- Last edited
- 06/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Malaria is a disease of great public health concern and it is one of the leading causes of death especially in developing countries and tropical regions of the world. There is still no vaccine available. According to the 2015 World Malaria Report, there were 214 million cases of malaria globally in 2015 (uncertainty range 149–303 million) and 438000 malaria deaths (range 236 000–635 000) representing a decrease in malaria cases and deaths of 37% and 60% since 2000, respectively. The burden was heaviest in the WHO African Region, where an estimated 90% of all malaria deaths occurred, and in children less than 5 years, who accounted for more than two thirds of all deaths.
The study is evaluating if Photodynamic Therapy (PDT; a treatment that involves light-sensitive medicine and a light source to destroy abnormal cells) might be a safe and effective treatment tool for Malaria patients.
Who can participate?
Adults aged 18 years and above with uncomplicated malaria from Ibadan, Nigeria and its environs.
What does the study involve?
Patients in the treatment group receive 5 PDT treatments within 14 days and are checked for safety (WBC and PVC) and efficacy of PDT (parasite count).
Patients in the control group receive standard ACT therapy while same measurements are done.
What are the possible benefits and risks of participating?
Benefits: Faster and more effective parasite clearance and relief of symptoms in treatment group expected.
Risks: Denial of standard ACT therapy
Where is the study run from?
State Hospital (Nigeria)
When is the study starting and how long is it expected to run for?
April 2019 to November 2021
Who is funding the study?
ISLA Research Group and Weber Medical, Germany.
Who is the main contact?
Robert Weber, robert.weber@webermedical.com
Contact information
Scientific
Hinter der Pumpe 6
Lauenfoerde
37697
Germany
 ORCID ID |
0000-0001-6567-4688 |
|---|---|
| Phone | +49 1724590153 |
| robert.weber@global-heartbeat.org |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Treatment |
| Scientific title | Evaluation of anti-microbial photodynamic therapy (using riboflavin as sensitizer) as a safe and effective treatment option for malaria |
| Study objectives | Proof of concept: Anti-microbial photodynamic therapy (using riboflavin as sensitizer) as a safe and effective treatment option for Malaria (p. falciparum). aPDT reduces parasite counts more effectively than conventional ACT treatment. |
| Ethics approval(s) | Approved 10/04/2019, Oyo State Research Ethics Review Committee (Ministry of Health, Department of Planning, Research and Statistics Divison, Oyo State of Nigeria, Nigeria; +234 8116308821; info@oyostate.gov.ng), ref: AD 13/479/1192 |
| Health condition(s) or problem(s) studied | Malaria (p. falciparum) |
| Intervention | Comparison between treatment and control group, both composed of patients suffering from Malaria (p. falciparum). Treatment group receives aPDT treatments, control group conventional ACT therapy. No masking. No randomization. Usage of Riboflavin as photosensitizer. Activation by systemic (intravenous) application of 447nm blue laser light and 370 nm ultraviolet (UVA) light. Subsequent intravenous laser therapy with green, yellow and red light. Treatment time: 90 min; 5 treatments in total within 14 days. Follow up on day 28 after first treatment with both groups. |
| Intervention type | Mixed |
| Primary outcome measure | Parasite count on day 0, day 2, day 4, day 8, day 14 and day 28 by blood test |
| Secondary outcome measures | Safety measurements on day 0, day 2, day 4, day 8, day 14 and day 28 by blood test: 1. White blood cell count 2. Packed cell volume test (hematocrit) |
| Overall study start date | 10/04/2019 |
| Completion date | 01/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 124 |
| Key inclusion criteria | Adults aged 18 years and above with uncomplicated malaria from Ibadan, Nigeria and its environs. |
| Key exclusion criteria | 1. Age <18 years 2. Pregnancy |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Ibadan
10000
Nigeria
Sponsor information
Charity
Hinter der Pumpe 6
Lauenfoerde
37697
Germany
| Phone | +49 1724590153 |
|---|---|
| info@global-heartbeat.org | |
| Website | https://www.global-heartbeat.org |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
06/09/2022: Trial's existence confirmed by Ministry of Health, Oyo State of Nigeria.
