Malaria in PregnancyPhase 3IPTp in PNGNCT01136850
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
A Phase 3 study testing chloroquine, sulphadoxine pyrimethamine, LLIN and azithromycin, sulphadoxine pyrimethamine, LLIN in people with Malaria in Pregnancy and Sexually Transmitted Infections, run by University of Melbourne at 1 site in Papua New Guinea.
Trial summary
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy, Sexually Transmitted Infections, Anaemia
- What is being tested?
- chloroquine, sulphadoxine pyrimethamine, LLIN and azithromycin, sulphadoxine pyrimethamine, LLIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,793 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Nov 2009to Jan 2013
- Phase
- Phase 3
- 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 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant
- 14-26 weeks'gestation
- permanent resident of study area
- exclusive use of study health facilities for primary health care
- Age is between 16 and 49 years
Who cannot join
- Known chronic illness, e.g. TB, diabetes, renal failure
- Severe anaemia requiring hospitalisation (Hb < 6 g/dl accompanied by symptoms requiring urgent treatment)
- permanent disability, that prevents or impedes study participation and/or comprehension
- Known multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinea Institute of Medical Research
Madang, Madang Province
About this study
Official title: Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.
- Being tested
- chloroquine, sulphadoxine pyrimethamine, LLIN, azithromycin, sulphadoxine pyrimethamine, LLIN
- Keywords
- Plasmodium falciparum, Plasmodium vivax, azithromycin, sulphadoxine pyrimethamine, low birth weight, haemoglobin, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum
- Medical subject headings
- Sexually Transmitted Diseases, Anemia, Malaria, Falciparum, Malaria, Vivax, Treponemal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquine, sulphadoxine pyrimethamine, LLINDrug
Also called sulfadoxine-pyrimethamine
> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
< 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
Given at enrolment, 14-26 weeks gestation, by mouth.
azithromycin, sulphadoxine pyrimethamine, LLINDrug
Also called Zithromax, sulfadoxine-pyrimethamine
sulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days).
Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation.
| Study group | Role | What they receive |
|---|---|---|
| SP, chloroquine treatment; bed net | Active comparator | Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net Receives: Drug: chloroquine, sulphadoxine pyrimethamine, LLIN |
| 3 x SP plus azithromycin; bed nets | Experimental | Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net. Receives: Drug: azithromycin, sulphadoxine pyrimethamine, LLIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women delivering low birth weight babies, <2500 g
Measured: At delivery
Secondary outcomes (11)
Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology
Measured: at delivery
Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).
Measured: At delivery
Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy
From enrolment at 14-26 weeks gestation, until delivery
Measured: up to 26 weeks
Incidence of symptomatic malaria during pregnancy
From enrolment at 14-26 weeks until delivery
Measured: Up to 26 weeks
Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).
Measured: 28-34 week gestation study visit
Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications
From enrolment at 14-26 weeks gestation until delivery
Measured: 14-26 weeks
Prevalence of drug resistance markers in parasites infecting women in late pregnancy, particularly in the P falciparum and P vivax dihydrofolate reductase and dihydropteroate synthase enzymes, associated with SP resistance
Measured: at delivery
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery
Measured: at delivery
Maternal, perinatal and infant mortality rates
maternal mortality is during pregnancy and until 6 weeks post partum. Perinatal mortality is from 28 weeks gestation until 6 weeks postpartum. Infant mortality is from irth to 12 months of age
Measured: Mothers; up to 32 weeks, from enrolment at 14-26 weeks gestation, until delivery. Pernatal: 16 weeks, from 28 weeks gestation to 4 weeks of age. Infant: from live birth to 1 year of age
Impact of IPTp on development of immunity to malaria in pregnancy
Measured: at delivery
Characteristics of parasites infecting pregnant women
Measured: Up to 26 weeks, from 14-26 weeks gestation until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, The University of Western Australia, Walter and Eliza Hall Institute of Medical Research, University of Barcelona
- Responsible party
- Principal investigator, Stephen Rogerson, University of Melbourne
- Investigators
- Stephen J Rogerson, FRACP PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136850
- Sponsor's protocol ID
- 70270
- Acronym
- IPTp in PNG
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2010
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steketee RW, Nahlen BL, Parise ME, Menendez C. The burden of malaria in pregnancy in malaria-endemic areas. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):28-35. doi: 10.4269/ajtmh.2001.64.28.
PubMed 11425175Guyatt HL, Snow RW. The epidemiology and burden of Plasmodium falciparum-related anemia among pregnant women in sub-Saharan Africa. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):36-44. doi: 10.4269/ajtmh.2001.64.36.
PubMed 11425176Brabin B, Piper C. Anaemia- and malaria-attributable low birthweight in two populations in Papua New Guinea. Ann Hum Biol. 1997 Nov-Dec;24(6):547-55. doi: 10.1080/03014469700005312.
PubMed 9395740Benet A, Khong TY, Ura A, Samen R, Lorry K, Mellombo M, Tavul L, Baea K, Rogerson SJ, Cortes A. Placental malaria in women with South-East Asian ovalocytosis. Am J Trop Med Hyg. 2006 Oct;75(4):597-604.
PubMed 17038679Allen SJ, Raiko A, O'Donnell A, Alexander ND, Clegg JB. Causes of preterm delivery and intrauterine growth retardation in a malaria endemic region of Papua New Guinea. Arch Dis Child Fetal Neonatal Ed. 1998 Sep;79(2):F135-40. doi: 10.1136/fn.79.2.f135.
PubMed 9828741Schultz LJ, Steketee RW, Macheso A, Kazembe P, Chitsulo L, Wirima JJ. The efficacy of antimalarial regimens containing sulfadoxine-pyrimethamine and/or chloroquine in preventing peripheral and placental Plasmodium falciparum infection among pregnant women in Malawi. Am J Trop Med Hyg. 1994 Nov;51(5):515-22. doi: 10.4269/ajtmh.1994.51.515.
PubMed 7985742Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22. doi: 10.4269/ajtmh.1998.59.813.
PubMed 9840604Verhoeff FH, Brabin BJ, Chimsuku L, Kazembe P, Russell WB, Broadhead RL. An evaluation of the effects of intermittent sulfadoxine-pyrimethamine treatment in pregnancy on parasite clearance and risk of low birthweight in rural Malawi. Ann Trop Med Parasitol. 1998 Mar;92(2):141-50. doi: 10.1080/00034989859979.
PubMed 9625909Shulman CE, Dorman EK, Cutts F, Kawuondo K, Bulmer JN, Peshu N, Marsh K. Intermittent sulphadoxine-pyrimethamine to prevent severe anaemia secondary to malaria in pregnancy: a randomised placebo-controlled trial. Lancet. 1999 Feb 20;353(9153):632-6. doi: 10.1016/s0140-6736(98)07318-8.
PubMed 10030329Casey GJ, Ginny M, Uranoli M, Mueller I, Reeder JC, Genton B, Cowman AF. Molecular analysis of Plasmodium falciparum from drug treatment failure patients in Papua New Guinea. Am J Trop Med Hyg. 2004 Mar;70(3):251-5.
PubMed 15031512ter Kuile FO, van Eijk AM, Filler SJ. Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA. 2007 Jun 20;297(23):2603-16. doi: 10.1001/jama.297.23.2603.
PubMed 17579229Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.
PubMed 18000538Unger HW, Bleicher A, Ome-Kaius M, Aitken EH, Rogerson SJ. Associations of maternal iron deficiency with malaria infection in a cohort of pregnant Papua New Guinean women. Malar J. 2022 May 26;21(1):153. doi: 10.1186/s12936-022-04177-8.
PubMed 35619134Unger HW, Laurita Longo V, Bleicher A, Ome-Kaius M, Karl S, Simpson JA, Karahalios A, Aitken EH, Rogerson SJ. The relationship between markers of antenatal iron stores and birth outcomes differs by malaria prevention regimen-a prospective cohort study. BMC Med. 2021 Oct 5;19(1):236. doi: 10.1186/s12916-021-02114-1.
PubMed 34607575Aitken EH, Damelang T, Ortega-Pajares A, Alemu A, Hasang W, Dini S, Unger HW, Ome-Kaius M, Nielsen MA, Salanti A, Smith J, Kent S, Hogarth PM, Wines BD, Simpson JA, Chung AW, Rogerson SJ. Developing a multivariate prediction model of antibody features associated with protection of malaria-infected pregnant women from placental malaria. Elife. 2021 Jun 29;10:e65776. doi: 10.7554/eLife.65776.
PubMed 34181872
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea
- ClinicalTrials.gov ID
- NCT01136850
- Acronym / sponsor ID
- IPTp in PNG / 70270
- Keywords
- Plasmodium falciparum, Plasmodium vivax, azithromycin, sulphadoxine pyrimethamine, low birth weight, haemoglobin, Chlamydia trachomatis, Neisseria gonorrhoeae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,793 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, The University of Western Australia, Walter and Eliza Hall Institute of Medical Research, University of Barcelona
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP, chloroquine treatment; bed net | Active comparator | Drug: chloroquine, sulphadoxine pyrimethamine, LLINTreatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net |
| 3 x SP plus azithromycin; bed nets | Experimental | Drug: azithromycin, sulphadoxine pyrimethamine, LLINThree x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- pregnant
- 14-26 weeks'gestation
- permanent resident of study area
- exclusive use of study health facilities for primary health care
- Age is between 16 and 49 years
Key exclusion criteria (4 listed)
- Known chronic illness, e.g. TB, diabetes, renal failure
- Severe anaemia requiring hospitalisation (Hb < 6 g/dl accompanied by symptoms requiring urgent treatment)
- permanent disability, that prevents or impedes study participation and/or comprehension
- Known multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroquine, sulphadoxine pyrimethamine, LLINAlso: sulfadoxine-pyrimethamine> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. < 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. Given at enrolment, 14-26 weeks gestation, by mouth. | Drug | SP, chloroquine treatment; bed net |
| azithromycin, sulphadoxine pyrimethamine, LLINAlso: Zithromax, sulfadoxine-pyrimethaminesulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days). Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation. | Drug | 3 x SP plus azithromycin; bed nets |
Primary outcome
Proportion of women delivering low birth weight babies, <2500 g
Time frame: At delivery
11 secondary outcomes
Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology
Time frame: at delivery
Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).
Time frame: At delivery
Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy
Time frame: up to 26 weeks
Incidence of symptomatic malaria during pregnancy
Time frame: Up to 26 weeks
Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).
Time frame: 28-34 week gestation study visit
Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications
Time frame: 14-26 weeks
Prevalence of drug resistance markers in parasites infecting women in late pregnancy, particularly in the P falciparum and P vivax dihydrofolate reductase and dihydropteroate synthase enzymes, associated with SP resistance
Time frame: at delivery
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery
Time frame: at delivery
Maternal, perinatal and infant mortality rates
Time frame: Mothers; up to 32 weeks, from enrolment at 14-26 weeks gestation, until delivery. Pernatal: 16 weeks, from 28 weeks gestation to 4 weeks of age. Infant: from live birth to 1 year of age
Impact of IPTp on development of immunity to malaria in pregnancy
Time frame: at delivery
Characteristics of parasites infecting pregnant women
Time frame: Up to 26 weeks, from 14-26 weeks gestation until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Background: PubMed 11425175Steketee RW, Nahlen BL, Parise ME, Menendez C. The burden of malaria in pregnancy in malaria-endemic areas. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):28-35. doi: 10.4269/ajtmh.2001.64.28.
- Background: PubMed 11425176Guyatt HL, Snow RW. The epidemiology and burden of Plasmodium falciparum-related anemia among pregnant women in sub-Saharan Africa. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):36-44. doi: 10.4269/ajtmh.2001.64.36.
- Background: PubMed 9395740Brabin B, Piper C. Anaemia- and malaria-attributable low birthweight in two populations in Papua New Guinea. Ann Hum Biol. 1997 Nov-Dec;24(6):547-55. doi: 10.1080/03014469700005312.
- Background: PubMed 17038679Benet A, Khong TY, Ura A, Samen R, Lorry K, Mellombo M, Tavul L, Baea K, Rogerson SJ, Cortes A. Placental malaria in women with South-East Asian ovalocytosis. Am J Trop Med Hyg. 2006 Oct;75(4):597-604.
- Background: PubMed 9828741Allen SJ, Raiko A, O'Donnell A, Alexander ND, Clegg JB. Causes of preterm delivery and intrauterine growth retardation in a malaria endemic region of Papua New Guinea. Arch Dis Child Fetal Neonatal Ed. 1998 Sep;79(2):F135-40. doi: 10.1136/fn.79.2.f135.
- Background: PubMed 7985742Schultz LJ, Steketee RW, Macheso A, Kazembe P, Chitsulo L, Wirima JJ. The efficacy of antimalarial regimens containing sulfadoxine-pyrimethamine and/or chloroquine in preventing peripheral and placental Plasmodium falciparum infection among pregnant women in Malawi. Am J Trop Med Hyg. 1994 Nov;51(5):515-22. doi: 10.4269/ajtmh.1994.51.515.
- Background: PubMed 9840604Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22. doi: 10.4269/ajtmh.1998.59.813.
- Background: PubMed 9625909Verhoeff FH, Brabin BJ, Chimsuku L, Kazembe P, Russell WB, Broadhead RL. An evaluation of the effects of intermittent sulfadoxine-pyrimethamine treatment in pregnancy on parasite clearance and risk of low birthweight in rural Malawi. Ann Trop Med Parasitol. 1998 Mar;92(2):141-50. doi: 10.1080/00034989859979.
- Background: PubMed 10030329Shulman CE, Dorman EK, Cutts F, Kawuondo K, Bulmer JN, Peshu N, Marsh K. Intermittent sulphadoxine-pyrimethamine to prevent severe anaemia secondary to malaria in pregnancy: a randomised placebo-controlled trial. Lancet. 1999 Feb 20;353(9153):632-6. doi: 10.1016/s0140-6736(98)07318-8.
- Background: PubMed 15031512Casey GJ, Ginny M, Uranoli M, Mueller I, Reeder JC, Genton B, Cowman AF. Molecular analysis of Plasmodium falciparum from drug treatment failure patients in Papua New Guinea. Am J Trop Med Hyg. 2004 Mar;70(3):251-5.
- Background: PubMed 17579229ter Kuile FO, van Eijk AM, Filler SJ. Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA. 2007 Jun 20;297(23):2603-16. doi: 10.1001/jama.297.23.2603.
- Background: PubMed 18000538Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.
- home page of umbrella organisation coordinating this and other trials on malaria in pregnancyLink provided by the sponsor.
- home page of Department of Central contact person, Dr RogersonLink provided by the sponsor.
- home page of Papua New Guinea Institute of Medical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Rogerson, FRACP PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chloroquine, sulphadoxine pyrimethamine, LLIN and azithromycin, sulphadoxine pyrimethamine, LLIN in people with Malaria in Pregnancy and Sexually Transmitted Infections, run by University of Melbourne at 1 site in Papua New Guinea.
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 5 inclusion and 4 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 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Proportion of women delivering low birth weight babies, <2500 g (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136850, which also lists 19 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 23 Apr 2013.