Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201912897645869 Date of Approval: 27/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and efficacy of photodynamic therapy (with riboflavin as sensitizer) for treatment of malaria in adult Nigerian population
Official scientific title Safety and efficacy of photodynamic therapy (with riboflavin as sensitizer) for treatment of malaria in adult Nigerian population: a Phase II study
Brief summary describing the background and objectives of the trial This is to study the safety of photodynamic therapy given in five alternate sessions over eight days in adults (18 years and above) with uncomplicated falciparum malaria in an area of high malaria transmission intensity compared to the safety of a standard ACT malaria therapy. In light of mosquitoes’ insecticide resistance and parasite resistance to antimalarial medicines, new treatments options need to be developed if malaria is to be eradicated globally. Antimicrobial Photodynamic Therapy is a potential new treatment option for malaria based on the combination of a photosensitizer that is selectively localized in the target tissue and the intravenous application of light of appropriate wavelength to activate the photosensitizer, resulting in photodamage and cell death. The innovation has also been found to have a destructive effect on microbes in vitro, therefore, in the face of drug and insecticide resistance, low level laser is a potential viable alternative and solution to the malaria menace. This study will go a long into perfecting the aPDT therapy for malaria as many studies have not investigated this possibility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 06/01/2020
Actual trial start date
Anticipated date of last follow up 09/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Photodynamic Therapy Five alternate sessions of treatment 8 days Riboflavin Photodynamic Therapy (RPDT) containing 200mg riboflavin solution; 100
Control Group Oral Artemisin Combination Therapy two times daily 3 days two times daily of artemether (60 -80mg) + lumefantrine (360 - 480mg) or artesunate (100 - 200mg) + lumefantrine (220-440mg) or artesunate (100 - 200mg) + amodiaquine (270-540mg) or artesunate (100 - 200mg) + sulphadoxine-pyrimethamine(1000/50 - 1500/75mg) 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients older than 18 years of age, Not on any form of treatment or prophylaxis for malaria, and Who gave an informed consent to participate in the study. Patients with complicated malaria (haemolytic anaemia, cerebral malaria, algid malaria, nephropathy etc), Those who are on antimalarial treatment or prophylaxis, Pregnant and lactating mothers, Those with concurrent or underlying illnesses, Those with known drug allergy, and Those who did not give informed consent will be excluded from the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/04/2019 Ministry of Health Department of Planning Research and Statistics Oyo State of Nigeria
Ethics Committee Address
Street address City Postal code Country
State Secretariat, Ibadan Ibadan 200211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of observed and self-reported non-serious adverse events 28 days
Secondary Outcome Incidence of serious adverse events over the 28 days observation period ACPR rate until D28 Early treatment failure (ETF) rate Late clinical failure (LCF) rate at D14 and D28 Late parasitological failure (LPF) rate at D14 and D28 Fever clearance time Parasite clearance time Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline Days 2, 3, 7, 14 and 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adeoyo State Hospital Adeoyo Maternity Hospital, Yemetu, Ibadan Ibadan 200211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Weber Medical Germany 4th floor, Group Medical, Queen Elizabeth Road, Mokola, Ibadan Lauenforde 37697 Germany
Future Minds Development Initiative 4th Floor, Group Medical, Queen Elizabeth Road, Ibadan Ibadan 200211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Future Minds Development Initiative 4th Floor, group Medicals, Queen Elizabeth Road, Mokola Ibadan 200211 Nigeria Other Collaborative Groups
Secondary Sponsor Weber Medical 4, 37697 Sohnreystrae Lauenforde 37697 Germany Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Prof Samuel Taiwo Ladoke Akintola Univetsity of technology, Ogbomosho Ogbomosho 210211 Nigeria
Dr Tunde Ali 4th Floor, Group Medical, Queen Elizabeth Road, Mokola, Ibadan Ibadan 200211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Taiwo Samuel sstaiwo@lautech.edu.ng 08033436344 Lautech, Ogbomosho
City Postal code Country Position/Affiliation
Ogbomosho Nigeria Head of Department
Role Name Email Phone Street address
Scientific Enquiries Tunde Ali habeeb@edokita.com +19057416858 4th floor, Group Medicals, Queen Elizabeth Road, Mokola
City Postal code Country Position/Affiliation
Ibadan Nigeria Managing Director
Role Name Email Phone Street address
Public Enquiries Ubong Ekpo ubong@edokita.com +2348031954447 4th Floor, Group Medicals, Queen Elizabeth Road, Mokola
City Postal code Country Position/Affiliation
Ibadan Nigeria Programmes and Research Officer
Role Name Email Phone Street address
Public Enquiries Yetunde Omotosho yetunde@edokita.com +2348169311296 4th Floor, Group Medicals, Queen Elizabeth Road, Mokola
City Postal code Country Position/Affiliation
Ibadan Nigeria Grants and Funds Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data Sharing Statement 1. Individual patient data will be available for sharing 2. Data that will be shared include Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) 3. Other available documents to be shared Study Protocol, Statistical Analysis Plan, Informed Consent form, 4. Date of data availability would be Immediately following publication, and no end date 5. Data would be available to Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose 6. Type of analysis for which data would be available would be basically To achieve aims in the approved proposal 7. Data would be available on site of publication Informed Consent Form,Statistical Analysis Plan,Study Protocol Would be available upon publication with no end date Paid access criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information